azithromycin

Generic: azithromycin

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin
Labeler cardinal health 107, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

azithromycin dihydrate 250 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-3374
Product ID 55154-3374_e6490132-6f7a-479f-8b30-ea2c7d6737ea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065398
Listing Expiration 2026-12-31
Marketing Start 2024-07-02

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 551543374
Hyphenated Format 55154-3374

Supplemental Identifiers

RxCUI
308460
UPC
0055154337403
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 ANDA065398 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BAG (55154-3374-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

55154-3374-0 10 BLISTER PACK in 1 BAG (55154-3374-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

azithromycin dihydrate (250 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": "e6490132-6f7a-479f-8b30-ea2c7d6737ea", "openfda": {"upc": ["0055154337403"], "unii": ["5FD1131I7S"], "rxcui": ["308460"], "spl_set_id": ["ea128124-8712-4998-be46-47d43ef127d4"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-3374-0)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "55154-3374-0", "marketing_start_date": "20240702"}], "brand_name": "azithromycin", "product_id": "55154-3374_e6490132-6f7a-479f-8b30-ea2c7d6737ea", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "55154-3374", "generic_name": "azithromycin", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "250 mg/1"}], "application_number": "ANDA065398", "marketing_category": "ANDA", "marketing_start_date": "20240702", "listing_expiration_date": "20261231"}