azithromycin dihydrate

Generic: azithromycin dihydrate

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin dihydrate
Generic Name azithromycin dihydrate
Labeler coupler llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

azithromycin dihydrate 250 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1502
Product ID 67046-1502_2cc99fae-a6c4-8893-e063-6394a90aa3ef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208250
Listing Expiration 2026-12-31
Marketing Start 2025-01-28

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461502
Hyphenated Format 67046-1502

Supplemental Identifiers

RxCUI
308460
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
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1502-3)
source: ndc

Packages (1)

67046-1502-3 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1502-3)

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": "2cc99fae-a6c4-8893-e063-6394a90aa3ef", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["308460"], "spl_set_id": ["2cc99fae-a72c-8893-e063-6394a90aa3ef"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1502-3)", "package_ndc": "67046-1502-3", "marketing_start_date": "20250128"}], "brand_name": "Azithromycin Dihydrate", "product_id": "67046-1502_2cc99fae-a6c4-8893-e063-6394a90aa3ef", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "67046-1502", "generic_name": "Azithromycin Dihydrate", "labeler_name": "Coupler LLC", "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": "20250128", "listing_expiration_date": "20261231"}