Metformin hydrochloride

Manufacturing Establishments3

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

Patheon Puerto Rico, Inc.

Labeler

Oceanside Pharmaceuticals

DUNS Number

143814544

Bausch Health Companies Inc.

Labeler

Oceanside Pharmaceuticals

DUNS Number

253292734

Carton Service, Incorporated

Labeler

Oceanside Pharmaceuticals

DUNS Number

928861723

Products3

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

Product Details

NDC Product Code

68682-018

Application Number

NDA021748

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

August 1, 2019

Ingredients

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990Class: IACT

CROSPOVIDONE (15 MPA.S AT 5%)Inactive

Code: 68401960MKClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

GLYCERYL DIBEHENATEInactive

Code: R8WTH25YS2Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

MetforminActive

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

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT