azithromycin

Generic: azithromycin

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

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin
Labeler a-s medication solutions
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

azithromycin dihydrate 200 mg/5mL

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-4458
Product ID 50090-4458_57c5f28a-3308-4eb6-ae6d-9e911f1f6989
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211147
Listing Expiration 2026-12-31
Marketing Start 2018-08-06

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500904458
Hyphenated Format 50090-4458

Supplemental Identifiers

RxCUI
141963
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 (source: ndc)
Generic Name azithromycin (source: ndc)
Application Number ANDA211147 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (50090-4458-0) / 30 mL in 1 BOTTLE
  • 30 CASE in 1 BOTTLE (50090-4458-1) / 24 mL in 1 CASE
source: ndc

Packages (2)

Ingredients (1)

azithromycin dihydrate (200 mg/5mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "57c5f28a-3308-4eb6-ae6d-9e911f1f6989", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["141963"], "spl_set_id": ["22a2bdcb-3012-42fb-ac66-d1d879100940"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50090-4458-0)  / 30 mL in 1 BOTTLE", "package_ndc": "50090-4458-0", "marketing_start_date": "20190806"}, {"sample": false, "description": "30 CASE in 1 BOTTLE (50090-4458-1)  / 24 mL in 1 CASE", "package_ndc": "50090-4458-1", "marketing_start_date": "20190806"}], "brand_name": "Azithromycin", "product_id": "50090-4458_57c5f28a-3308-4eb6-ae6d-9e911f1f6989", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "50090-4458", "generic_name": "Azithromycin", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "200 mg/5mL"}], "application_number": "ANDA211147", "marketing_category": "ANDA", "marketing_start_date": "20180806", "listing_expiration_date": "20261231"}