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 50228-446
Product ID 50228-446_2cd1dc49-0219-4df8-8865-96ac77e77334
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213334
Listing Expiration 2026-12-31
Marketing Start 2021-04-16

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50228446
Hyphenated Format 50228-446

Supplemental Identifiers

RxCUI
1807888 1807915
UPC
0350228446907 0350228445016
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 ANDA213334 (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 (50228-446-05)
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-446-30)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-446-90)
source: ndc

Packages (3)

50228-446-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-446-05) 50228-446-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-446-30) 50228-446-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-446-90)

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": "2cd1dc49-0219-4df8-8865-96ac77e77334", "openfda": {"upc": ["0350228446907", "0350228445016"], "unii": ["786Z46389E"], "rxcui": ["1807888", "1807915"], "spl_set_id": ["1452fbb1-e591-4a51-9f83-8a8a6a780b52"], "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 (50228-446-05)", "package_ndc": "50228-446-05", "marketing_start_date": "20210416"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-446-30)", "package_ndc": "50228-446-30", "marketing_start_date": "20210416"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-446-90)", "package_ndc": "50228-446-90", "marketing_start_date": "20210416"}], "brand_name": "Metformin Hydrochloride", "product_id": "50228-446_2cd1dc49-0219-4df8-8865-96ac77e77334", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "50228-446", "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": "ANDA213334", "marketing_category": "ANDA", "marketing_start_date": "20210416", "listing_expiration_date": "20261231"}