azithromycin dihydrate

Generic: azithromycin dihydrate

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

Drug Facts

Product Profile

Brand Name azithromycin dihydrate
Generic Name azithromycin dihydrate
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 76420-046
Product ID 76420-046_ae7775dd-3ddd-58b8-e053-2995a90ad046
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208250
Listing Expiration 2026-12-31
Marketing Start 2019-07-01

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420046
Hyphenated Format 76420-046

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 dihydrate (source: ndc)
Generic Name azithromycin dihydrate (source: ndc)
Application Number ANDA208250 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 6 TABLET, FILM COATED in 1 BLISTER PACK (76420-046-06)
source: ndc

Packages (1)

76420-046-06 6 TABLET, FILM COATED in 1 BLISTER PACK (76420-046-06)

Ingredients (1)

azithromycin dihydrate (250 mg/1)

Linked Drug Pages (1)

Azithromycin Dihydrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ae7775dd-3ddd-58b8-e053-2995a90ad046", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["308460", "749783"], "spl_set_id": ["b08bd8fc-20da-4623-9211-ae669452b16d"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET, FILM COATED in 1 BLISTER PACK (76420-046-06)", "package_ndc": "76420-046-06", "marketing_start_date": "20200904"}], "brand_name": "Azithromycin Dihydrate", "product_id": "76420-046_ae7775dd-3ddd-58b8-e053-2995a90ad046", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "76420-046", "generic_name": "Azithromycin Dihydrate", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin Dihydrate", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "250 mg/1"}], "application_number": "ANDA208250", "marketing_category": "ANDA", "marketing_start_date": "20190701", "listing_expiration_date": "20261231"}