Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
NuCare Pharmaceuticals,Inc.
NuCare Pharmaceuticals,Inc.
010632300
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Valsartan and Hydrochlorothiazide
Product Details
NDC Product Code
68071-4376Application Number
ANDA201662Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 16, 2021CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
ValsartanActive
Code: 80M03YXJ7IClass: ACTIBQuantity: 320 mg in 1 1
HydrochlorothiazideActive
Code: 0J48LPH2THClass: ACTIBQuantity: 25 mg in 1 1