Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Preferred Pharmaceuticals Inc
791119022
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Preferred Pharmaceuticals Inc
Preferred Pharmaceuticals Inc
Preferred Pharmaceuticals Inc
791119022
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
METFORMIN HYDROCHLORIDE
Product Details
NDC Product Code
68788-7901Application Number
ANDA203769Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 28, 2023MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 850 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
ACACIAInactive
Code: 5C5403N26OClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2Class: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT