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.
Phendimetrazine Tartrate
Product Details
NDC Product Code
66267-394Application Number
ANDA091042Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 13, 2022SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1MClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
PhendimetrazineActive
Code: 6985IP0T80Class: ACTIBQuantity: 35 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT