Nardil
NARDIL (Phenelzine Sulfate Tablets, USP)
Approved
Approval ID
513a41d0-37d4-4355-8a6d-a2c643bce6fa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 9, 2020
Manufacturers
FDA
Parke-Davis Div of Pfizer Inc
DUNS: 829076962
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Phenelzine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0071-0350
Application NumberNDA011909
Product Classification
M
Marketing Category
C73594
G
Generic Name
Phenelzine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 9, 2020
FDA Product Classification
INGREDIENTS (8)
PHENELZINE SULFATEActive
Quantity: 15 mg in 1 1
Code: 2681D7P965
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT