Phendimetrazine Tartrate (Page 3 of 3)

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

DEA Order Form Required.

Manufactured by:

KVK-TECH, INC.

110 Terry Drive Suite 200

Newtown, PA 18940-1850

Item ID # 006080/05 09/10

Manufacturer’s Code: 10702

C:\Documents and Settings\avyas\Desktop\phend-outsert\SPL\phendimetrazine-image-b.jpgC:\Documents and Settings\avyas\Desktop\phend-outsert\SPL\phendimetrazine-image-b.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP
(click image for full-size original)

PHENDIMETRAZINE TARTRATE
phendimetrazine tartrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66267-394(NDC:10702-077)
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENDIMETRAZINE TARTRATE (PHENDIMETRAZINE) PHENDIMETRAZINE TARTRATE 35 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FD&C YELLOW NO. 5
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color yellow Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code K;77
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66267-394-60 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091042 09/15/2010
Labeler — NuCare Pharmaceuticals, Inc, (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals, Inc. 010632300 repack (66267-394)

Revised: 01/2022 NuCare Pharmaceuticals, Inc,

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