azithromycin

Generic: azithromycin

Labeler: bionpharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin
Labeler bionpharma inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

azithromycin dihydrate 600 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-173
Product ID 69452-173_0d48a6b6-8e7f-a3ae-e063-6394a90ada0c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209999
Listing Expiration 2026-12-31
Marketing Start 2018-12-26

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69452173
Hyphenated Format 69452-173

Supplemental Identifiers

RxCUI
204844
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 ANDA209999 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (69452-173-13)
source: ndc

Packages (1)

69452-173-13 30 TABLET, FILM COATED in 1 BOTTLE (69452-173-13)

Ingredients (1)

azithromycin dihydrate (600 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": "0d48a6b6-8e7f-a3ae-e063-6394a90ada0c", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["204844"], "spl_set_id": ["a2754618-3df1-4b89-aa09-fdff4b71b7e4"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (69452-173-13)", "package_ndc": "69452-173-13", "marketing_start_date": "20181226"}], "brand_name": "Azithromycin", "product_id": "69452-173_0d48a6b6-8e7f-a3ae-e063-6394a90ada0c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "69452-173", "generic_name": "Azithromycin", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "600 mg/1"}], "application_number": "ANDA209999", "marketing_category": "ANDA", "marketing_start_date": "20181226", "listing_expiration_date": "20261231"}