azithromycin

Generic: azithromycin

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

azithromycin dihydrate 500 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8251
Product ID 63629-8251_599dcee2-f09c-4130-bb7c-e477acf7db1d
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 636298251
Hyphenated Format 63629-8251

Supplemental Identifiers

RxCUI
248656
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
  • 30 TABLET, FILM COATED in 1 BOTTLE (63629-8251-1)
  • 5 TABLET, FILM COATED in 1 BOTTLE (63629-8251-2)
  • 2 TABLET, FILM COATED in 1 BOTTLE (63629-8251-3)
  • 6 TABLET, FILM COATED in 1 BOTTLE (63629-8251-4)
source: ndc

Packages (4)

63629-8251-1 30 TABLET, FILM COATED in 1 BOTTLE (63629-8251-1) 63629-8251-2 5 TABLET, FILM COATED in 1 BOTTLE (63629-8251-2) 63629-8251-3 2 TABLET, FILM COATED in 1 BOTTLE (63629-8251-3) 63629-8251-4 6 TABLET, FILM COATED in 1 BOTTLE (63629-8251-4)

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": "599dcee2-f09c-4130-bb7c-e477acf7db1d", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["248656"], "spl_set_id": ["a81212ef-76b6-4bd7-8706-3d2b05ee34f9"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63629-8251-1)", "package_ndc": "63629-8251-1", "marketing_start_date": "20191218"}, {"sample": false, "description": "5 TABLET, FILM COATED in 1 BOTTLE (63629-8251-2)", "package_ndc": "63629-8251-2", "marketing_start_date": "20191105"}, {"sample": false, "description": "2 TABLET, FILM COATED in 1 BOTTLE (63629-8251-3)", "package_ndc": "63629-8251-3", "marketing_start_date": "20191105"}, {"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE (63629-8251-4)", "package_ndc": "63629-8251-4", "marketing_start_date": "20191105"}], "brand_name": "Azithromycin", "product_id": "63629-8251_599dcee2-f09c-4130-bb7c-e477acf7db1d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "63629-8251", "generic_name": "Azithromycin", "labeler_name": "Bryant Ranch Prepack", "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"}