MedPath

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

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Nardil - FDA Drug Approval Details