azithromycin dihydrate

Generic: azithromycin dihydrate

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin dihydrate
Generic Name azithromycin dihydrate
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

azithromycin dihydrate 500 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7299
Product ID 50090-7299_ef8fc905-d91d-4a3e-8959-2d8955936116
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208249
Listing Expiration 2026-12-31
Marketing Start 2024-02-15

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500907299
Hyphenated Format 50090-7299

Supplemental Identifiers

RxCUI
248656
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 ANDA208249 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 2 TABLET, FILM COATED in 1 BOTTLE (50090-7299-0)
source: ndc

Packages (1)

50090-7299-0 2 TABLET, FILM COATED in 1 BOTTLE (50090-7299-0)

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": "ef8fc905-d91d-4a3e-8959-2d8955936116", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["248656"], "spl_set_id": ["b4c05e22-4a54-4948-abf8-8a479d465d30"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "2 TABLET, FILM COATED in 1 BOTTLE (50090-7299-0)", "package_ndc": "50090-7299-0", "marketing_start_date": "20241014"}], "brand_name": "Azithromycin Dihydrate", "product_id": "50090-7299_ef8fc905-d91d-4a3e-8959-2d8955936116", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "50090-7299", "generic_name": "Azithromycin dihydrate", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin Dihydrate", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "500 mg/1"}], "application_number": "ANDA208249", "marketing_category": "ANDA", "marketing_start_date": "20240215", "listing_expiration_date": "20261231"}