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 500 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-172
Product ID 69452-172_4526a56d-6695-5338-e063-6294a90aa2b0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210001
Listing Expiration 2026-12-31
Marketing Start 2019-03-12

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69452172
Hyphenated Format 69452-172

Supplemental Identifiers

RxCUI
248656 308460 749780 749783
UPC
0369452171134 0369452172131
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 ANDA210001 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (69452-172-13)
  • 3 BLISTER PACK in 1 CARTON (69452-172-72) / 3 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (69452-172-74) / 3 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (3)

69452-172-13 30 TABLET, FILM COATED in 1 BOTTLE (69452-172-13) 69452-172-72 3 BLISTER PACK in 1 CARTON (69452-172-72) / 3 TABLET, FILM COATED in 1 BLISTER PACK 69452-172-74 1 BLISTER PACK in 1 CARTON (69452-172-74) / 3 TABLET, FILM COATED in 1 BLISTER PACK

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": "4526a56d-6695-5338-e063-6294a90aa2b0", "openfda": {"upc": ["0369452171134", "0369452172131"], "unii": ["5FD1131I7S"], "rxcui": ["248656", "308460", "749780", "749783"], "spl_set_id": ["859bb02c-a4bc-46fa-9fc9-def1219b5dfb"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (69452-172-13)", "package_ndc": "69452-172-13", "marketing_start_date": "20190312"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (69452-172-72)  / 3 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "69452-172-72", "marketing_start_date": "20191010"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (69452-172-74)  / 3 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "69452-172-74", "marketing_start_date": "20191010"}], "brand_name": "Azithromycin", "product_id": "69452-172_4526a56d-6695-5338-e063-6294a90aa2b0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "69452-172", "generic_name": "Azithromycin", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "500 mg/1"}], "application_number": "ANDA210001", "marketing_category": "ANDA", "marketing_start_date": "20190312", "listing_expiration_date": "20261231"}