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 250 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-4601
Product ID 50090-4601_e5a7d412-de53-471b-a06e-68b3365865a2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208250
Marketing Start 2019-07-01
Marketing End 2026-11-30

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500904601
Hyphenated Format 50090-4601

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
  • 16 HOW SUPPLIED/STORAGE AND HANDLING Product: 50090-4601 NDC: 50090-4601-0 6 TABLET, FILM COATED in a BLISTER PACK / 1 in a CARTON NDC: 50090-4601-1 6 TABLET, FILM COATED in a BLISTER PACK / 2 in a CARTON
  • Azithromycin Dihydrate Label Image
source: label

Packages (0)

No package records.

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": "e5a7d412-de53-471b-a06e-68b3365865a2", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["308460"], "spl_set_id": ["df9b39b7-d42d-4c4b-b492-9fd228978dec"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [], "brand_name": "Azithromycin Dihydrate", "product_id": "50090-4601_e5a7d412-de53-471b-a06e-68b3365865a2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "50090-4601", "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": "250 mg/1"}], "application_number": "ANDA208250", "marketing_category": "ANDA", "marketing_end_date": "20261130", "marketing_start_date": "20190701"}