PHENDIMETRAZINE TARTRATE
Phendimetrazine Tartrate Extended-Release Capsules CIII
Approved
Approval ID
669fafd4-ac03-4bbc-ba86-28d1efbaf8c6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 10, 2022
Manufacturers
FDA
Virtus Pharmaceuticals, LLC
DUNS: 079659493
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 Code69543-409
Application NumberNDA018074
Product Classification
M
Marketing Category
C73594
G
Generic Name
PHENDIMETRAZINE TARTRATE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 10, 2022
FDA Product Classification
INGREDIENTS (11)
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
PHENDIMETRAZINE TARTRATEActive
Quantity: 105 mg in 1 1
Code: 6985IP0T80
Classification: ACTIB
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT