azithromycin Indications/Contra | FAERs | Orange Book | BioActivity |

Stem definitionDrug idCAS RN
antibiotics, produced by Streptomyces strains 276 83905-01-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • CP-62993
  • CP 62993
  • azithromycin
  • arzomicin
  • aziromycin
  • Azithromycin A
  • azithromycin monohydrate
  • azithromycin anhydrous
  • azithromycin dihydrate
  • azithromycin hydrate
A semi-synthetic macrolide antibiotic structurally related to ERYTHROMYCIN. It has been used in the treatment of Mycobacterium avium intracellulare infections, toxoplasmosis, and cryptosporidiosis.
  • Molecular weight: 749.00
  • Formula: C38H72N2O12
  • CLOGP: 2.64
  • LIPINSKI: 2
  • HAC: 14
  • HDO: 5
  • TPSA: 180.08
  • ALOGS: -3.16
  • ROTB: 7

Drug dosage:

DoseUnitRoute
0.30 g O
0.50 g P

Approvals:

DateAgencyCompanyOrphan
Nov. 1, 1991 FDA

FDA Adverse Event Reporting System

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug hypersensitivity 5367.97 27.45 1459 5211 66941 4565381
No adverse event 1199.81 27.45 361 6309 21802 4610520
Product quality issue 754.32 27.45 248 6422 19851 4612471
Product packaging quantity issue 653.81 27.45 120 6550 734 4631588
Rash 623.28 27.45 353 6317 108035 4524287
Product dose omission 555.92 27.45 279 6391 66683 4565639
Inappropriate schedule of product administration 446.25 27.45 173 6497 22197 4610125
Drug interaction 437.74 27.45 235 6435 64273 4568049
Vomiting 431.63 27.45 290 6380 119409 4512913
Urticaria 369.40 27.45 179 6491 39394 4592928
Diarrhoea 323.03 27.45 267 6403 149918 4482404
Drug-induced liver injury 317.28 27.45 105 6565 8486 4623836
Stevens-Johnson syndrome 312.71 27.45 104 6566 8535 4623787
Electrocardiogram QT prolonged 282.47 27.45 112 6558 15183 4617139
Nausea 276.84 27.45 263 6407 177070 4455252
Dyspnoea 267.44 27.45 232 6438 138753 4493569
Pruritus 263.25 27.45 177 6493 72395 4559927
Pyrexia 249.76 27.45 200 6470 106944 4525378
Anosmia 237.64 27.45 57 6613 1400 4630922
Drug ineffective 231.26 27.45 244 6426 185817 4446505
Deafness 213.65 27.45 69 6601 5150 4627172
Hypersensitivity 210.65 27.45 122 6548 38299 4594023
International normalised ratio increased 189.29 27.45 87 6583 16901 4615421
Ageusia 187.35 27.45 58 6612 3768 4628554
Abdominal pain 174.46 27.45 128 6542 59896 4572426
Rhabdomyolysis 168.67 27.45 84 6586 19474 4612848
Product prescribing error 162.39 27.45 61 6609 7125 4625197
Incorrect product administration duration 156.95 27.45 51 6619 3876 4628446
Pneumonia 156.75 27.45 151 6519 102664 4529658
Torsade de pointes 156.52 27.45 51 6619 3910 4628412
Cardiac arrest 152.60 27.45 95 6575 33912 4598410
Tinnitus 148.19 27.45 61 6609 9072 4623250
Erythema 139.11 27.45 97 6573 41843 4590479
Eye irritation 135.26 27.45 49 6621 5165 4627157
Alanine aminotransferase increased 129.11 27.45 80 6590 28293 4604029
Cough 125.25 27.45 102 6568 55485 4576837
Drug reaction with eosinophilia and systemic symptoms 124.21 27.45 58 6612 11655 4620667
Aspartate aminotransferase increased 122.89 27.45 74 6596 24864 4607458
Condition aggravated 119.13 27.45 101 6569 58070 4574252
Cholestasis 118.71 27.45 50 6620 7870 4624452
Ventricular fibrillation 115.83 27.45 44 6626 5293 4627029
Acute kidney injury 113.90 27.45 107 6563 70324 4561998
Toxic epidermal necrolysis 112.95 27.45 45 6625 6147 4626175
Malaise 110.86 27.45 118 6552 90039 4542283
Palpitations 107.83 27.45 68 6602 24778 4607544
Drug eruption 106.74 27.45 44 6626 6559 4625763
Ventricular tachycardia 105.41 27.45 45 6625 7319 4625003
Vanishing bile duct syndrome 99.90 27.45 22 6648 364 4631958
Hepatomegaly 96.66 27.45 35 6635 3680 4628642
Hepatocellular injury 95.94 27.45 43 6627 7857 4624465
Jaundice 91.28 27.45 48 6622 12426 4619896
Angioedema 90.54 27.45 56 6614 19709 4612613
Hepatitis 89.41 27.45 47 6623 12158 4620164
Loss of consciousness 87.79 27.45 69 6601 35613 4596709
Ocular hyperaemia 87.71 27.45 38 6632 6402 4625920
Chills 86.98 27.45 63 6607 28776 4603546
Skin exfoliation 85.70 27.45 44 6626 10843 4621479
Erythema multiforme 85.13 27.45 33 6637 4190 4628132
Hypotension 84.14 27.45 89 6581 67311 4565011
Hepatic failure 83.36 27.45 46 6624 13103 4619219
Blood alkaline phosphatase increased 82.72 27.45 45 6625 12462 4619860
Tachycardia 82.65 27.45 63 6607 31082 4601240
Abdominal pain upper 82.30 27.45 66 6604 35049 4597273
Medication error 82.08 27.45 47 6623 14369 4617953
Weight decreased 80.87 27.45 79 6591 54385 4577937
Anaphylactic shock 80.47 27.45 38 6632 7819 4624503
Hepatitis cholestatic 76.74 27.45 27 6643 2611 4629711
Abdominal discomfort 74.34 27.45 57 6613 28351 4603971
Viral infection 73.35 27.45 36 6634 8062 4624260
Tubulointerstitial nephritis 73.31 27.45 33 6637 6086 4626236
Seizure 72.94 27.45 72 6598 50165 4582157
Rash maculo-papular 71.58 27.45 36 6634 8493 4623829
Respiratory failure 71.05 27.45 57 6613 30269 4602053
Agranulocytosis 69.83 27.45 34 6636 7483 4624839
Dizziness 69.29 27.45 98 6572 99773 4532549
Hypoacusis 69.21 27.45 32 6638 6277 4626045
Bronchitis 67.85 27.45 47 6623 19993 4612329
Syncope 66.24 27.45 57 6613 33338 4598984
Multiple organ dysfunction syndrome 65.89 27.45 45 6625 18711 4613611
Chromaturia 65.63 27.45 30 6640 5731 4626591
Hyperhidrosis 63.30 27.45 53 6617 29864 4602458
Eye pain 63.08 27.45 32 6638 7685 4624637
Anaphylactic reaction 62.98 27.45 43 6627 17867 4614455
Hepatitis acute 62.50 27.45 24 6646 2968 4629354
Pancytopenia 60.96 27.45 48 6622 24805 4607517
Off label use 60.77 27.45 106 6564 129007 4503315
Pharyngeal oedema 60.70 27.45 28 6642 5461 4626861
Clostridium difficile colitis 58.65 27.45 25 6645 4045 4628277
Pallor 57.76 27.45 30 6640 7562 4624760
Swollen tongue 56.51 27.45 31 6639 8719 4623603
Hepatic function abnormal 56.38 27.45 37 6633 14399 4617923
Dermatitis bullous 55.76 27.45 22 6648 2925 4629397
Swelling face 55.45 27.45 37 6633 14803 4617519
Dermatitis exfoliative 55.19 27.45 22 6648 3004 4629318
Mycobacterium avium complex infection 55.13 27.45 16 6654 830 4631492
Liver disorder 54.66 27.45 35 6635 13063 4619259
Tremor 54.52 27.45 53 6617 36206 4596116
Cyanosis 54.37 27.45 27 6643 6195 4626127
Bradycardia 54.08 27.45 43 6627 22526 4609796
Liver injury 53.79 27.45 25 6645 4960 4627362
Bacterial infection 52.33 27.45 24 6646 4619 4627703
Asthenia 51.69 27.45 79 6591 86084 4546238
Dehydration 51.20 27.45 55 6615 42235 4590087
Transaminases increased 51.16 27.45 30 6640 9576 4622746
Arrhythmia 50.96 27.45 34 6636 13598 4618724
Blood bilirubin increased 50.80 27.45 33 6637 12619 4619703
Delirium 50.56 27.45 33 6637 12719 4619603
Burning sensation 50.22 27.45 32 6638 11840 4620482
Product administration error 49.80 27.45 28 6642 8256 4624066
Eye swelling 49.62 27.45 26 6644 6671 4625651
Wheezing 49.47 27.45 31 6639 11143 4621179
Toxicity to various agents 48.88 27.45 70 6600 71970 4560352
Lip oedema 48.76 27.45 17 6653 1599 4630723
Eosinophilia 48.56 27.45 26 6644 6967 4625355
Asthma 47.94 27.45 36 6634 17338 4614984
Sinusitis 47.54 27.45 40 6630 22672 4609650
Dysphagia 47.43 27.45 42 6628 25489 4606833
Hallucination, visual 46.85 27.45 24 6646 5878 4626444
Incorrect dose administered 46.58 27.45 37 6633 19348 4612974
Aphthous ulcer 46.24 27.45 18 6652 2309 4630013
Decreased appetite 46.11 27.45 60 6610 56337 4575985
Dysgeusia 46.07 27.45 33 6637 14786 4617536
Pseudomembranous colitis 46.05 27.45 15 6655 1146 4631176
Gastrointestinal disorder 45.92 27.45 34 6636 16027 4616295
Upper respiratory tract infection 45.87 27.45 32 6638 13755 4618567
Cardio-respiratory arrest 45.85 27.45 37 6633 19785 4612537
Prothrombin level decreased 45.26 27.45 12 6658 444 4631878
Acute generalised exanthematous pustulosis 44.95 27.45 19 6651 3011 4629311
Throat tightness 44.86 27.45 24 6646 6422 4625900
Insomnia 44.70 27.45 53 6617 45292 4587030
Chest pain 44.69 27.45 56 6614 50644 4581678
Deafness neurosensory 44.56 27.45 15 6655 1269 4631053
Conjunctivitis 44.09 27.45 21 6649 4399 4627923
Hallucination 43.04 27.45 34 6636 17634 4614688
Coagulopathy 42.98 27.45 23 6647 6157 4626165
Hepatic steatosis 42.81 27.45 23 6647 6205 4626117
Vision blurred 42.52 27.45 39 6631 24764 4607558
Haemolytic anaemia 42.13 27.45 20 6650 4158 4628164
Pain 42.01 27.45 75 6595 92795 4539527
Blood lactate dehydrogenase increased 41.15 27.45 24 6646 7579 4624743
Leukopenia 40.85 27.45 36 6634 21700 4610622
Ototoxicity 40.54 27.45 12 6658 667 4631655
Hypoxic-ischaemic encephalopathy 39.87 27.45 15 6655 1754 4630568
Drug level increased 39.84 27.45 22 6648 6264 4626058
Headache 39.79 27.45 86 6584 122287 4510035
Oedema peripheral 39.63 27.45 48 6622 41924 4590398
Liver function test abnormal 39.55 27.45 30 6640 14662 4617660
Drug intolerance 38.85 27.45 35 6635 21711 4610611
C-reactive protein increased 38.61 27.45 28 6642 12784 4619538
Deafness unilateral 38.28 27.45 13 6657 1130 4631192
Product storage error 38.23 27.45 26 6644 10723 4621599
Myalgia 37.94 27.45 47 6623 42001 4590321
Product dispensing error 37.91 27.45 21 6649 6016 4626306
Atrial fibrillation 36.72 27.45 40 6630 31175 4601147
Parosmia 36.70 27.45 13 6657 1281 4631041
Blood creatine phosphokinase increased 36.65 27.45 29 6641 15070 4617252
Exposure during pregnancy 36.62 27.45 41 6629 32930 4599392
Rash erythematous 36.38 27.45 25 6645 10484 4621838
Hepatic enzyme increased 36.23 27.45 31 6639 17960 4614362
Heart rate increased 35.42 27.45 31 6639 18511 4613811
Renal failure 35.34 27.45 45 6625 41324 4590998
Swelling 35.32 27.45 35 6635 24447 4607875
Oral discomfort 34.90 27.45 14 6656 1942 4630380
Tooth discolouration 34.71 27.45 10 6660 505 4631817
Paraesthesia 34.50 27.45 41 6629 35092 4597230
Incorrect route of product administration 34.40 27.45 25 6645 11448 4620874
Lymphocyte stimulation test positive 34.35 27.45 10 6660 524 4631798
Lymphadenopathy 34.28 27.45 24 6646 10368 4621954
White blood cell count increased 34.25 27.45 28 6642 15239 4617083
Hepatic necrosis 34.12 27.45 14 6656 2058 4630264
Confusional state 33.89 27.45 48 6622 48786 4583536
Disseminated intravascular coagulation 33.75 27.45 21 6649 7452 4624870
Choking 33.47 27.45 15 6655 2734 4629588
Feeling abnormal 33.33 27.45 41 6629 36364 4595958
Thrombocytopenia 33.30 27.45 47 6623 47626 4584696
Face oedema 33.28 27.45 20 6650 6670 4625652
Oedema 33.14 27.45 30 6640 18721 4613601
Visual field defect 32.98 27.45 15 6655 2830 4629492
Respiratory distress 32.83 27.45 24 6646 11092 4621230
Palmar erythema 32.71 27.45 9 6661 384 4631938
Laryngeal pain 32.55 27.45 13 6657 1783 4630539
Laryngeal oedema 32.32 27.45 14 6656 2354 4629968
Monoclonal gammopathy 32.22 27.45 8 6662 227 4632095
Overdose 31.99 27.45 44 6626 43515 4588807
Anxiety 31.57 27.45 46 6624 47965 4584357
Hypophagia 30.58 27.45 20 6650 7728 4624594
Jaundice cholestatic 30.52 27.45 12 6658 1579 4630743
Shock 30.36 27.45 21 6649 8895 4623427
Rash pruritic 30.35 27.45 24 6646 12459 4619863
Activated partial thromboplastin time prolonged 30.12 27.45 14 6656 2775 4629547
Prothrombin time prolonged 30.10 27.45 15 6655 3466 4628856
Pathogen resistance 29.99 27.45 14 6656 2802 4629520
Pharyngeal erythema 29.73 27.45 9 6661 540 4631782
Adjustment disorder 29.72 27.45 8 6662 314 4632008
Gastritis 29.58 27.45 20 6650 8166 4624156
Anaemia 28.81 27.45 55 6615 71505 4560817
Product dropper issue 28.56 27.45 7 6663 188 4632134
Uveitis 28.51 27.45 14 6656 3134 4629188
Haematochezia 28.47 27.45 22 6648 11042 4621280
Back pain 28.35 27.45 45 6625 50554 4581768
Abdominal distension 28.34 27.45 27 6643 17962 4614360
Rash macular 28.16 27.45 17 6653 5715 4626607
Foetal death 28.15 27.45 13 6657 2539 4629783
Renal tubular necrosis 28.06 27.45 15 6655 4003 4628319
Pyloric stenosis 28.04 27.45 8 6662 390 4631932
Cheilitis 27.79 27.45 11 6659 1473 4630849
Chest discomfort 27.74 27.45 30 6640 23180 4609142
Blister 27.70 27.45 22 6648 11487 4620835
Liquid product physical issue 27.67 27.45 8 6662 409 4631913

Pharmacologic Action:

SourceCodeDescription
ATC J01FA10 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS
Macrolides
ATC J01RA07 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
COMBINATIONS OF ANTIBACTERIALS
Combinations of antibacterials
ATC S01AA26 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFECTIVES
Antibiotics
FDA EPC N0000175935 Macrolide Antimicrobial
FDA Chemical/Ingredient N0000007529 Macrolides
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Acute gonococcal cervicitis indication 20943002 DOID:10615
Acute gonococcal urethritis indication 29864006
Streptococcal tonsillitis indication 41582007
Pneumonia due to Mycoplasma pneumoniae indication 46970008
Bacterial pneumonia indication 53084003 DOID:874
Haemophilus influenzae pneumonia indication 70036007
Acute bacterial sinusitis indication 75498004
Bacterial conjunctivitis indication 128350005 DOID:9700
Urethritis due to Chlamydia trachomatis indication 179101003
Pulmonary Mycobacterium avium complex infection indication 186342000
Chlamydial pelvic inflammatory disease indication 188463006
Acute bacterial bronchitis indication 233598009
Pneumococcal pneumonia indication 233607000
Chlamydial pneumonia indication 233609002
Chancroid indication 266143009 DOID:13778
Pelvic inflammatory disease due to Mycoplasma hominis indication 270550006
Streptococcus pyogenes infection indication 302809008
Infective otitis media indication 312218008
Infection due to Staphylococcus aureus indication 406602003
Acute exacerbation of chronic bronchitis indication 425748003
Pneumonia due to Staphylococcus aureus indication 441658007
Moraxella Catarrhalis Acute Otitis Media indication
Skin and Skin Structure Streptococcus Agalactiae Infection indication
Chlamydia Cervicitis indication
Legionella Pneumophila Pneumonia indication
Pelvic Inflammatory Disease with Neisseria Gonorrhea indication
Pneumococcal Acute Otitis Media indication
Haemophilus Influenzae Acute Otitis Media indication
Moraxella Catarrhalis Pneumonia indication
Pyrexia of unknown origin off-label use 7520000
Traveler's diarrhea off-label use 11840006
Enteric campylobacteriosis off-label use 18081009
Pertussis off-label use 27836007
Gonorrhea of rectum off-label use 42746002
Gonorrhea of pharynx off-label use 74372003
Coronavirus infection off-label use 186747009
Boutonneuse fever off-label use 186774005 DOID:14095
Toxoplasmosis associated with acquired immunodeficiency syndrome off-label use 421666009
Prevention of Bacterial Endocarditis off-label use
Inflammatory Disease of Female Pelvic Organs off-label use
Sexual Transmitted Disease Exposure from Sexual Assault off-label use
Jaundice contraindication 18165001
Torsades de pointes contraindication 31722008
Chronic heart failure contraindication 48447003
Myasthenia gravis contraindication 91637004 DOID:437
Prolonged QT interval contraindication 111975006
Hearing disorder contraindication 128540005
Liver function tests abnormal contraindication 166603001
Disease of liver contraindication 235856003 DOID:409
Pseudomembranous enterocolitis contraindication 397683000
Congenital long QT syndrome contraindication 442917000

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.45 acidic
pKa2 8.87 Basic
pKa3 8.24 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 2GM BASE/BOT ZMAX PF PRISM CV N050797 June 10, 2005 DISCN FOR SUSPENSION, EXTENDED RELEASE ORAL 6984403 Feb. 14, 2024 METHOD OF TREATING BACTERIAL INFECTIONS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Canalicular multispecific organic anion transporter 1 Transporter IC50 4.16 WOMBAT-PK
Multidrug resistance protein 1 Transporter IC50 3.70 WOMBAT-PK
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 3.39 WOMBAT-PK
Motilin receptor GPCR AGONIST EC50 5.50 IUPHAR
SARS-CoV-2 Virus INHIBITOR EC50 5.67 SCIENTIFIC LITERATURE

External reference:

IDSource
4020019 VUID
N0000148074 NUI
C0052796 UMLSCUI
D02134 KEGG_DRUG
5FD1131I7S UNII
117772-70-0 SECONDARY_CAS_RN
96034006 SNOMEDCT_US
4020019 VANDF
72442 MMSL
003635 NDDF
18631 RXNORM
387531004 SNOMEDCT_US
4238 MMSL
d00091 MMSL
CHEMBL529 ChEMBL_ID
DB00207 DRUGBANK_ID
CHEMBL1200502 ChEMBL_ID
6197 INN_ID
ZIT PDB_CHEM_ID
6510 IUPHAR_LIGAND_ID
D017963 MESH_DESCRIPTOR_UI
447043 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-0400 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS NDA 17 sections
ZITHROMAX HUMAN PRESCRIPTION DRUG LABEL 1 0069-3051 POWDER, FOR SUSPENSION 1 g ORAL NDA 18 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-3060 TABLET, FILM COATED 250 mg ORAL NDA 17 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-3070 TABLET, FILM COATED 500 mg ORAL NDA 17 sections
ZITHROMAX HUMAN PRESCRIPTION DRUG LABEL 1 0069-3080 TABLET, FILM COATED 600 mg ORAL NDA 18 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-3110 POWDER, FOR SUSPENSION 100 mg ORAL NDA 17 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-3120 POWDER, FOR SUSPENSION 200 mg ORAL NDA 17 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-3130 POWDER, FOR SUSPENSION 200 mg ORAL NDA 17 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-3140 POWDER, FOR SUSPENSION 200 mg ORAL NDA 17 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-3150 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS NDA 17 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-4061 TABLET, FILM COATED 250 mg ORAL NDA 17 sections
Zithromax HUMAN PRESCRIPTION DRUG LABEL 1 0069-9500 TABLET, FILM COATED 250 mg ORAL UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE 19 sections
Azithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0093-2026 POWDER, FOR SUSPENSION 200 mg ORAL ANDA 17 sections
Azithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0093-2027 POWDER, FOR SUSPENSION 100 mg ORAL ANDA 17 sections
Azithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0409-0144 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS ANDA 16 sections
azithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0527-2370 TABLET, FILM COATED 250 mg ORAL ANDA 17 sections
azithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0527-2395 TABLET, FILM COATED 500 mg ORAL ANDA 17 sections
Azithromycin Dihydrate HUMAN PRESCRIPTION DRUG LABEL 1 0527-2750 TABLET, COATED 500 mg ORAL Unapproved drug for use in drug shortage 2 sections
Azithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0781-1496 TABLET, FILM COATED 250 mg ORAL ANDA 19 sections
Azithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0781-1497 TABLET, FILM COATED 600 mg ORAL ANDA 18 sections
Azithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0781-1941 TABLET, FILM COATED 500 mg ORAL ANDA 19 sections
Azithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0781-5776 TABLET, FILM COATED 250 mg ORAL ANDA 17 sections
Azithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0781-5789 TABLET, FILM COATED 500 mg ORAL ANDA 17 sections
Azithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0781-5793 TABLET, FILM COATED 600 mg ORAL ANDA 17 sections
Azithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0781-8089 TABLET, FILM COATED 250 mg ORAL ANDA 17 sections
Azithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0781-8090 TABLET, FILM COATED 500 mg ORAL ANDA 17 sections
Azithromycin HUMAN PRESCRIPTION DRUG LABEL 1 0781-8091 TABLET, FILM COATED 600 mg ORAL ANDA 17 sections
Azithromycin Dihydrate HUMAN PRESCRIPTION DRUG LABEL 1 0904-6405 TABLET, FILM COATED 250 mg ORAL ANDA 19 sections
azithromycin monohydrate HUMAN PRESCRIPTION DRUG LABEL 1 0904-6708 TABLET 250 mg ORAL ANDA 17 sections
azithromycin HUMAN PRESCRIPTION DRUG LABEL 1 10019-648 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS NDA AUTHORIZED GENERIC 18 sections