azithromycin

Generic: azithromycin

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin
Labeler american health packaging
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

azithromycin dihydrate 500 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-753
Product ID 60687-753_37616a61-0547-5914-e063-6294a90a2cb0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065399
Listing Expiration 2026-12-31
Marketing Start 2023-08-01

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60687753
Hyphenated Format 60687-753

Supplemental Identifiers

RxCUI
248656 308460
UNII
5FD1131I7S

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 ANDA065399 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (60687-753-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-753-11)
source: ndc

Packages (1)

60687-753-21 30 BLISTER PACK in 1 CARTON (60687-753-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-753-11)

Ingredients (1)

azithromycin dihydrate (500 mg/1)

Linked Drug Pages (1)

Azithromycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "37616a61-0547-5914-e063-6294a90a2cb0", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["248656", "308460"], "spl_set_id": ["6169e56c-10fb-448d-ab0f-14e54fcf2817"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (60687-753-21)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-753-11)", "package_ndc": "60687-753-21", "marketing_start_date": "20230801"}], "brand_name": "Azithromycin", "product_id": "60687-753_37616a61-0547-5914-e063-6294a90a2cb0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "60687-753", "generic_name": "Azithromycin", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "500 mg/1"}], "application_number": "ANDA065399", "marketing_category": "ANDA", "marketing_start_date": "20230801", "listing_expiration_date": "20261231"}