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PHENDIMETRAZINE TARTRATE

Approved
Approval ID

79719e0a-587f-4f60-a8e5-a28edf5bd7da

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 21, 2011

Manufacturers
FDA

STAT RX USA LLC

DUNS: 786036330

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 Code16590-642
Application NumberANDA085588
Product Classification
M
Marketing Category
C73584
G
Generic Name
PHENDIMETRAZINE TARTRATE
Product Specifications
Route of AdministrationORAL
Effective DateApril 21, 2011
FDA Product Classification

INGREDIENTS (8)

PHENDIMETRAZINE TARTRATEActive
Quantity: 35 mg in 1 1
Code: 6985IP0T80
Classification: ACTIB
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT

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PHENDIMETRAZINE TARTRATE - FDA Drug Approval Details