metformin hydrochloride

Generic: metformin hydrochloride

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

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler a-s medication solutions
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-5397
Product ID 50090-5397_d54849ef-363f-43c5-ab89-c491f90fea0d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206145
Listing Expiration 2026-12-31
Marketing Start 2018-10-27

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500905397
Hyphenated Format 50090-5397

Supplemental Identifiers

RxCUI
860975
UNII
786Z46389E

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 metformin hydrochloride (source: ndc)
Generic Name metformin hydrochloride (source: ndc)
Application Number ANDA206145 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5397-0)
source: ndc

Packages (1)

50090-5397-0 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5397-0)

Ingredients (1)

metformin hydrochloride (500 mg/1)

Linked Drug Pages (1)

Metformin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d54849ef-363f-43c5-ab89-c491f90fea0d", "openfda": {"unii": ["786Z46389E"], "rxcui": ["860975"], "spl_set_id": ["d60139c2-fd35-4ab4-af7e-7410481edc2e"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5397-0)", "package_ndc": "50090-5397-0", "marketing_start_date": "20201202"}], "brand_name": "Metformin Hydrochloride", "product_id": "50090-5397_d54849ef-363f-43c5-ab89-c491f90fea0d", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "50090-5397", "generic_name": "Metformin Hydrochloride", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA206145", "marketing_category": "ANDA", "marketing_start_date": "20181027", "listing_expiration_date": "20261231"}