Temazepam (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 17856-0146-1

TEMAZEPAM CIV Capsules, USP

15 mg

Rx only

100 capsules

label 1
(click image for full-size original)
TEMAZEPAM temazepam capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17856-0148(NDC:67877-146)
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
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
FD&C YELLOW NO. 6
TITANIUM DIOXIDE
AMMONIA
ALCOHOL
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
SHELLAC
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
FD&C BLUE NO. 1
GELATIN
Product Characteristics
Color BLUE (blue opaque cap) , WHITE (white opaque body) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 15mg;Novel121
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17856-0148-1 100 POUCH in 1 PACKAGE contains a POUCH
1 1 CAPSULE in 1 POUCH This package is contained within the PACKAGE (17856-0148-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071456 04/21/1987
Labeler — ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
Name Address ID/FEI Operations
ATLANTIC BIOLOGICALS CORP. 047437707 relabel (17856-0148), repack (17856-0148)

Revised: 11/2019 ATLANTIC BIOLOGICALS CORP.

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