azithromycin

Generic: azithromycin

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

azithromycin dihydrate 250 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-213
Product ID 76420-213_23b371e7-b120-3dc4-e063-6294a90a585d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065211
Listing Expiration 2026-12-31
Marketing Start 2005-11-14

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420213
Hyphenated Format 76420-213

Supplemental Identifiers

RxCUI
308460 749783
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 ANDA065211 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 6 DOSE PACK in 1 CARTON (76420-213-06) / 1 TABLET, FILM COATED in 1 DOSE PACK
source: ndc

Packages (1)

76420-213-06 6 DOSE PACK in 1 CARTON (76420-213-06) / 1 TABLET, FILM COATED in 1 DOSE 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": "23b371e7-b120-3dc4-e063-6294a90a585d", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["308460", "749783"], "spl_set_id": ["22a4d2b3-daea-4d96-891f-4b9823629456"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "6 DOSE PACK in 1 CARTON (76420-213-06)  / 1 TABLET, FILM COATED in 1 DOSE PACK", "package_ndc": "76420-213-06", "marketing_start_date": "20220308"}], "brand_name": "Azithromycin", "product_id": "76420-213_23b371e7-b120-3dc4-e063-6294a90a585d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "76420-213", "generic_name": "Azithromycin", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "250 mg/1"}], "application_number": "ANDA065211", "marketing_category": "ANDA", "marketing_start_date": "20051114", "listing_expiration_date": "20261231"}