Metformin hydrochloride

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

NuCare Pharmaceuticals,Inc.

DUNS Number

010632300

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

68071-4525

Application Number

ANDA090564

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 11, 2021

Ingredients

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

POVIDONE K90Inactive

Code: RDH86HJV5ZClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

BLACKBERRYInactive

Code: 8A6OMU3I8LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Code: 786Z46389EClass: ACTIBQuantity: 1000 mg in 1 1