Phendimetrazine Tartrate
Rx Only
Approved
Approval ID
467ae7d7-e342-423b-be89-5d38c1abf3c9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 6, 2023
Manufacturers
FDA
PD-Rx Pharmaceuticals, Inc.
DUNS: 156893695
Products 1
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 Code43063-510
Application NumberANDA091042
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phendimetrazine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 6, 2023
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
PHENDIMETRAZINE TARTRATEActive
Quantity: 35 mg in 1 1
Code: 6985IP0T80
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT