azithromycin dihydrate

Generic: azithromycin dihydrate

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin dihydrate
Generic Name azithromycin dihydrate
Labeler advanced rx of tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

azithromycin dihydrate 500 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0412
Product ID 80425-0412_1d0e96cf-245e-cfb7-e063-6294a90a4ced
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065399
Listing Expiration 2026-12-31
Marketing Start 2024-07-10

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250412
Hyphenated Format 80425-0412

Supplemental Identifiers

RxCUI
248656 749780
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 ANDA065399 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (80425-0412-1) / 3 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

80425-0412-1 1 BLISTER PACK in 1 CARTON (80425-0412-1) / 3 TABLET in 1 BLISTER PACK

Ingredients (1)

azithromycin dihydrate (500 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": "1d0e96cf-245e-cfb7-e063-6294a90a4ced", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["248656", "749780"], "spl_set_id": ["1cec44fa-9597-3e58-e063-6394a90ae326"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (80425-0412-1)  / 3 TABLET in 1 BLISTER PACK", "package_ndc": "80425-0412-1", "marketing_start_date": "20240710"}], "brand_name": "azithromycin dihydrate", "product_id": "80425-0412_1d0e96cf-245e-cfb7-e063-6294a90a4ced", "dosage_form": "TABLET", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "80425-0412", "generic_name": "azithromycin dihydrate", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "azithromycin dihydrate", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "500 mg/1"}], "application_number": "ANDA065399", "marketing_category": "ANDA", "marketing_start_date": "20240710", "listing_expiration_date": "20261231"}