Phendimetrazine Tartrate
Rx Only
Approved
Approval ID
07bf3488-09e7-436f-af3f-94c35a7be025
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 11, 2019
Manufacturers
FDA
KVK-TECH, INC
DUNS: 173360061
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Phendimetrazine Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10702-077
Application NumberANDA091042
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phendimetrazine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2019
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
PHENDIMETRAZINE TARTRATEActive
Quantity: 35 mg in 1 1
Code: 6985IP0T80
Classification: ACTIB
Phendimetrazine Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10702-045
Application NumberANDA091042
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phendimetrazine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2019
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
PHENDIMETRAZINE TARTRATEActive
Quantity: 35 mg in 1 1
Code: 6985IP0T80
Classification: ACTIB
Phendimetrazine Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10702-078
Application NumberANDA091042
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phendimetrazine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2019
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PHENDIMETRAZINE TARTRATEActive
Quantity: 35 mg in 1 1
Code: 6985IP0T80
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT