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 50090-4527
Product ID 50090-4527_73b54c1b-428f-40d2-b27e-79401310690e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208250
Listing Expiration 2026-12-31
Marketing Start 2019-07-01

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500904527
Hyphenated Format 50090-4527

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
  • 4 TABLET, FILM COATED in 1 BOTTLE (50090-4527-0)
source: ndc

Packages (1)

50090-4527-0 4 TABLET, FILM COATED in 1 BOTTLE (50090-4527-0)

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": "73b54c1b-428f-40d2-b27e-79401310690e", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["308460"], "spl_set_id": ["1c84a68b-3eaa-4dab-b5e5-e195c7652e67"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET, FILM COATED in 1 BOTTLE (50090-4527-0)", "package_ndc": "50090-4527-0", "marketing_start_date": "20190916"}], "brand_name": "Azithromycin Dihydrate", "product_id": "50090-4527_73b54c1b-428f-40d2-b27e-79401310690e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "50090-4527", "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_start_date": "20190701", "listing_expiration_date": "20261231"}