azithromycin

Generic: azithromycin

Labeler: redpharm drug
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin
Labeler redpharm drug
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

azithromycin dihydrate 500 mg/1

Manufacturer
Redpharm Drug

Identifiers & Regulatory

Product NDC 67296-1945
Product ID 67296-1945_46e92ad2-2f3f-cdb3-e063-6294a90a983a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207398
Listing Expiration 2026-12-31
Marketing Start 2018-07-05

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 672961945
Hyphenated Format 67296-1945

Supplemental Identifiers

RxCUI
248656 749780
UPC
0365862642301
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 ANDA207398 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 5 BLISTER PACK in 1 CARTON (67296-1945-5) / 3 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

67296-1945-5 5 BLISTER PACK in 1 CARTON (67296-1945-5) / 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": "46e92ad2-2f3f-cdb3-e063-6294a90a983a", "openfda": {"upc": ["0365862642301"], "unii": ["5FD1131I7S"], "rxcui": ["248656", "749780"], "spl_set_id": ["2fd25741-f014-3999-e063-6394a90acdd0"], "manufacturer_name": ["Redpharm Drug"]}, "finished": true, "packaging": [{"sample": false, "description": "5 BLISTER PACK in 1 CARTON (67296-1945-5)  / 3 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "67296-1945-5", "marketing_start_date": "20180705"}], "brand_name": "Azithromycin", "product_id": "67296-1945_46e92ad2-2f3f-cdb3-e063-6294a90a983a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "67296-1945", "generic_name": "Azithromycin", "labeler_name": "Redpharm Drug", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "500 mg/1"}], "application_number": "ANDA207398", "marketing_category": "ANDA", "marketing_start_date": "20180705", "listing_expiration_date": "20261231"}