Nardil, Page 3

Nardil has been found to be effective in depressed patients clinically characterized as “atypical,” “nonendogenous,” or “neurotic.” These patients often have mixed anxiety and depression and phobic or hypochondriacal features.

PRINCIPAL DISPLAY PANEL — 60 Tablet Bottle Label

NDC 0071-0350-60

60 Tablets
Rx only

Nardil®
(Phenelzine Sulfate
Tablets, USP)

15 mg*

Pfizer
Distributed by
Parke-Davis
Division of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL -- 60 Tablet Bottle Label
(click image for full-size original)
NARDIL
phenelzine sulfate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0071-0350
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Phenelzine Sulfate (Phenelzine) Phenelzine Sulfate 15 mg
Inactive Ingredients
Ingredient Name Strength
mannitol
croscarmellose sodium
povidone
edetate disodium
magnesium stearate
isopropyl alcohol
water
Product Characteristics
Color ORANGE Score no score
Shape ROUND (biconvex) Size 10mm
Flavor Imprint Code P;D;270
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0071-0350-60 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA011909 06/09/1961
Labeler — Parke-Davis Div of Pfizer Inc (829076962)
Establishment
Name Address ID/FEI Operations
Pfizer PGM 397047957 MANUFACTURE
Establishment
Name Address ID/FEI Operations
FARMEA 286080408 MANUFACTURE
Establishment
Name Address ID/FEI Operations
BASF Orgamol Pharma Solutions SA 480143502 API MANUFACTURE

Revised: 02/2011 Parke-Davis Div of Pfizer Inc

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