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
Routes
ORAL
Active Ingredients

azithromycin dihydrate 600 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1503
Product ID 67046-1503_2cc9449e-e4be-3667-e063-6294a90af6ba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065400
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 670461503
Hyphenated Format 67046-1503

Supplemental Identifiers

RxCUI
204844
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 ANDA065400 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1503-3)
source: ndc

Packages (1)

67046-1503-3 30 TABLET in 1 BLISTER PACK (67046-1503-3)

Ingredients (1)

azithromycin dihydrate (600 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": "2cc9449e-e4be-3667-e063-6294a90af6ba", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["204844"], "spl_set_id": ["2cc93e72-95ce-965b-e063-6394a90a8917"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1503-3)", "package_ndc": "67046-1503-3", "marketing_start_date": "20250128"}], "brand_name": "azithromycin dihydrate", "product_id": "67046-1503_2cc9449e-e4be-3667-e063-6294a90af6ba", "dosage_form": "TABLET", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "67046-1503", "generic_name": "azithromycin dihydrate", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "azithromycin dihydrate", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "600 mg/1"}], "application_number": "ANDA065400", "marketing_category": "ANDA", "marketing_start_date": "20250128", "listing_expiration_date": "20261231"}