metformin hydrochloride

Generic: metformin hydrochloride extended-release tablets

Labeler: sciegen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride extended-release tablets
Labeler sciegen pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1

Manufacturer
ScieGen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50228-504
Product ID 50228-504_dabc66fe-9cb1-3e39-e053-2995a90ab45f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214629
Listing Expiration 2026-12-31
Marketing Start 2022-02-22

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50228504
Hyphenated Format 50228-504

Supplemental Identifiers

RxCUI
1807894 1807917
UPC
0350228504058 0350228504607 0350228503600 0350228503303 0350228503051
UNII
786Z46389E

Packaging Origin

Original Packager
true

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 extended-release tablets (source: ndc)
Application Number ANDA214629 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-504-05)
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-504-30)
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-504-60)
source: ndc

Packages (3)

50228-504-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-504-05) 50228-504-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-504-30) 50228-504-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-504-60)

Ingredients (1)

metformin hydrochloride (1000 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": "dabc66fe-9cb1-3e39-e053-2995a90ab45f", "openfda": {"upc": ["0350228504058", "0350228504607", "0350228503600", "0350228503303", "0350228503051"], "unii": ["786Z46389E"], "rxcui": ["1807894", "1807917"], "spl_set_id": ["16dc4008-7b5e-4c6d-9bc8-8db96be911a1"], "manufacturer_name": ["ScieGen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-504-05)", "package_ndc": "50228-504-05", "marketing_start_date": "20220222"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-504-30)", "package_ndc": "50228-504-30", "marketing_start_date": "20220222"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-504-60)", "package_ndc": "50228-504-60", "marketing_start_date": "20220222"}], "brand_name": "Metformin Hydrochloride", "product_id": "50228-504_dabc66fe-9cb1-3e39-e053-2995a90ab45f", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "50228-504", "generic_name": "Metformin Hydrochloride Extended-Release Tablets", "labeler_name": "ScieGen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "ANDA214629", "marketing_category": "ANDA", "marketing_start_date": "20220222", "listing_expiration_date": "20261231"}