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FDA Approval

Metformin hydrochloride

CompanyNuCare Pharmaceuticals,Inc. (DUNS: 010632300)

Effective Date

February 18, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Metformin(500 mg in 1 1)

Manufacturing Establishments (1)

NuCare Pharmaceuticals,Inc.

Labeler

NuCare Pharmaceuticals,Inc.

DUNS Number

010632300

Products (1)

Metformin hydrochloride

NDC Product Code

68071-4560

Application Number

ANDA090564

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 18, 2021

Ingredients

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

POVIDONE K90Inactive

Code: RDH86HJV5ZClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

MetforminActive

Code: 786Z46389EClass: ACTIBQuantity: 500 mg in 1 1

BLACKBERRYInactive

Code: 8A6OMU3I8LClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

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