azithromycin

Generic: azithromycin

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin
Labeler mylan pharmaceuticals inc.
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

azithromycin dihydrate 1 g/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 59762-3051
Product ID 59762-3051_84a47d17-3a7d-4d2c-8dbe-3c2b6a9aefba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA050693
Marketing Start 1999-02-12
Marketing End 2026-04-29

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 597623051
Hyphenated Format 59762-3051

Supplemental Identifiers

RxCUI
204844 861416
UNII
5FD1131I7S

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name azithromycin (source: ndc)
Generic Name azithromycin (source: ndc)
Application Number NDA050693 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 3 PACKET in 1 BOX (59762-3051-2) / 1 POWDER, FOR SUSPENSION in 1 PACKET (59762-3051-5)
source: ndc

Packages (1)

59762-3051-2 3 PACKET in 1 BOX (59762-3051-2) / 1 POWDER, FOR SUSPENSION in 1 PACKET (59762-3051-5)

Ingredients (1)

azithromycin dihydrate (1 g/1)

Linked Drug Pages (1)

azithromycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "84a47d17-3a7d-4d2c-8dbe-3c2b6a9aefba", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["204844", "861416"], "spl_set_id": ["d470695c-c0d7-4361-8783-45f58a932ac4"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 PACKET in 1 BOX (59762-3051-2)  / 1 POWDER, FOR SUSPENSION in 1 PACKET (59762-3051-5)", "package_ndc": "59762-3051-2", "marketing_end_date": "20260429", "marketing_start_date": "19990212"}], "brand_name": "azithromycin", "product_id": "59762-3051_84a47d17-3a7d-4d2c-8dbe-3c2b6a9aefba", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "59762-3051", "generic_name": "AZITHROMYCIN", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "1 g/1"}], "application_number": "NDA050693", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_end_date": "20260429", "marketing_start_date": "19990212"}