Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
NuCare Pharmaceutials,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.
RISPERIDONE
Product Details
NDC Product Code
68071-4618Application Number
ANDA201003Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 22, 2021SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
RisperidoneActive
Code: L6UH7ZF8HCClass: ACTIBQuantity: 2 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT