Temazepam (Page 4 of 4)

08-2010M

7205

Sandoz Inc.

Princeton, NJ 08540

PRINCIPAL DISPLAY PANEL

Temazepam Caps, USP 30mg
(click image for full-size original)

Temazepam Caps, USP 30mg
(click image for full-size original)
TEMAZEPAM
temazepam capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0615-7808(NDC:0781-2201)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TEMAZEPAM (TEMAZEPAM) TEMAZEPAM 15 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
D&C YELLOW NO. 10
FD&C BLUE NO. 1
GELATIN
HYPROMELLOSE 2910 (3 MPA.S)
FERROSOFERRIC OXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
METHYLPARABEN
BUTYLPARABEN
PROPYLPARABEN
BENZYL ALCOHOL
SODIUM PROPIONATE
EDETATE CALCIUM DISODIUM
Product Characteristics
Color GREEN (green & white) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code GG531
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0615-7808-39 30 CAPSULE in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071427 01/12/1988
TEMAZEPAM
temazepam capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0615-7809(NDC:0781-2202)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TEMAZEPAM (TEMAZEPAM) TEMAZEPAM 30 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
D&C YELLOW NO. 10
FD&C BLUE NO. 1
GELATIN
HYPROMELLOSE 2910 (3 MPA.S)
FERROSOFERRIC OXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
METHYLPARABEN
BUTYLPARABEN
PROPYLPARABEN
BENZYL ALCOHOL
SODIUM PROPIONATE
EDETATE CALCIUM DISODIUM
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code GG532
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0615-7809-39 30 CAPSULE in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071428 01/12/1988
Labeler — NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
Name Address ID/FEI Operations
NCS HealthCare of KY, Inc dba Vangard Labs 050052943 REPACK (0615-7808), REPACK (0615-7809)

Revised: 07/2015 NCS HealthCare of KY, Inc dba Vangard Labs

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