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 500 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-4976
Product ID 68071-4976_1b2e96de-5ed6-c9e9-e063-6394a90a472e
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 680714976
Hyphenated Format 68071-4976

Supplemental Identifiers

RxCUI
248656 749780
UPC
0368071497632
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
  • 3 TABLET, FILM COATED in 1 BLISTER PACK (68071-4976-3)
source: ndc

Packages (1)

68071-4976-3 3 TABLET, FILM COATED in 1 BLISTER PACK (68071-4976-3)

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": "1b2e96de-5ed6-c9e9-e063-6394a90a472e", "openfda": {"upc": ["0368071497632"], "unii": ["5FD1131I7S"], "rxcui": ["248656", "749780"], "spl_set_id": ["8e7184e1-3c3c-cd87-e053-2a95a90a6eb6"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "3 TABLET, FILM COATED in 1 BLISTER PACK (68071-4976-3)", "package_ndc": "68071-4976-3", "marketing_start_date": "20190724"}], "brand_name": "Azithromycin", "product_id": "68071-4976_1b2e96de-5ed6-c9e9-e063-6394a90a472e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "68071-4976", "generic_name": "Azithromycin", "labeler_name": "NuCare Pharmaceuticals,Inc.", "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"}