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 500 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-589
Product ID 76420-589_04472220-f8c1-1f1a-e063-6294a90a2bb2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065223
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 76420589
Hyphenated Format 76420-589

Supplemental Identifiers

RxCUI
248656 308460 749780 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 ANDA065223 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 3 TABLET, FILM COATED in 1 BLISTER PACK (76420-589-03)
source: ndc

Packages (1)

76420-589-03 3 TABLET, FILM COATED in 1 BLISTER PACK (76420-589-03)

Ingredients (1)

azithromycin monohydrate (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": "04472220-f8c1-1f1a-e063-6294a90a2bb2", "openfda": {"unii": ["JTE4MNN1MD"], "rxcui": ["248656", "308460", "749780", "749783"], "spl_set_id": ["9c44af6d-8a9a-cb4c-e053-2a95a90afdac"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "3 TABLET, FILM COATED in 1 BLISTER PACK (76420-589-03)", "package_ndc": "76420-589-03", "marketing_start_date": "20230901"}], "brand_name": "Azithromycin", "product_id": "76420-589_04472220-f8c1-1f1a-e063-6294a90a2bb2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "76420-589", "generic_name": "Azithromycin", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN MONOHYDRATE", "strength": "500 mg/1"}], "application_number": "ANDA065223", "marketing_category": "ANDA", "marketing_start_date": "20060106", "listing_expiration_date": "20261231"}