azithromycin

Generic: azithromycin

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

azithromycin dihydrate 250 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-4812
Product ID 68071-4812_2d0644a1-e698-e6a7-e063-6394a90a3623
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207370
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 680714812
Hyphenated Format 68071-4812

Supplemental Identifiers

RxCUI
308460
UPC
0368071481228
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 ANDA207370 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 2 TABLET, FILM COATED in 1 BOTTLE (68071-4812-2)
source: ndc

Packages (1)

68071-4812-2 2 TABLET, FILM COATED in 1 BOTTLE (68071-4812-2)

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": "2d0644a1-e698-e6a7-e063-6394a90a3623", "openfda": {"upc": ["0368071481228"], "unii": ["5FD1131I7S"], "rxcui": ["308460"], "spl_set_id": ["a9cdb5ae-2aeb-c598-e053-2a95a90a8062"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "2 TABLET, FILM COATED in 1 BOTTLE (68071-4812-2)", "package_ndc": "68071-4812-2", "marketing_start_date": "20250131"}], "brand_name": "Azithromycin", "product_id": "68071-4812_2d0644a1-e698-e6a7-e063-6394a90a3623", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "68071-4812", "generic_name": "Azithromycin", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "250 mg/1"}], "application_number": "ANDA207370", "marketing_category": "ANDA", "marketing_start_date": "20180705", "listing_expiration_date": "20261231"}