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 monohydrate 250 mg/1

Manufacturer
ASCLEMED USA INC.

Identifiers & Regulatory

Product NDC 76420-403
Product ID 76420-403_37fce346-d60a-f2b1-e063-6294a90a632b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065225
Listing Expiration 2026-12-31
Marketing Start 2006-01-06

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420403
Hyphenated Format 76420-403

Supplemental Identifiers

RxCUI
308460 749783
UNII
JTE4MNN1MD

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 ANDA065225 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (76420-403-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

76420-403-06 1 BLISTER PACK in 1 CARTON (76420-403-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

azithromycin monohydrate (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": "37fce346-d60a-f2b1-e063-6294a90a632b", "openfda": {"unii": ["JTE4MNN1MD"], "rxcui": ["308460", "749783"], "spl_set_id": ["fcd9aba6-87ea-4298-86f7-96bdcc0c1c2f"], "manufacturer_name": ["ASCLEMED USA INC."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (76420-403-06)  / 6 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "76420-403-06", "marketing_start_date": "20250618"}], "brand_name": "Azithromycin", "product_id": "76420-403_37fce346-d60a-f2b1-e063-6294a90a632b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "76420-403", "generic_name": "Azithromycin", "labeler_name": "ASCLEMED USA INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN MONOHYDRATE", "strength": "250 mg/1"}], "application_number": "ANDA065225", "marketing_category": "ANDA", "marketing_start_date": "20060106", "listing_expiration_date": "20261231"}