Diazepam (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 10 mg Tablet Bottle Label

diaz10
(click image for full-size original)

CIV

10 mg

Diazepam Tablets, USP

30 Tablets Rx Only

DIAZEPAM
diazepam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67046-946(NDC:51862-063)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIAZEPAM (DIAZEPAM) DIAZEPAM 5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
D&C YELLOW NO. 10
Product Characteristics
Color yellow Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code DAN;5619;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67046-946-30 30 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071135 08/03/2016
DIAZEPAM
diazepam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67046-947(NDC:51862-064)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIAZEPAM (DIAZEPAM) DIAZEPAM 10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
FD&C BLUE NO. 1
Product Characteristics
Color blue Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code DAN;5620;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67046-947-30 30 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071136 08/03/2016
Labeler — Contract Pharmacy Services-PA (945429777)
Establishment
Name Address ID/FEI Operations
Coupler Enterprises 945429777 repack (67046-946), repack (67046-947)

Revised: 12/2018 Contract Pharmacy Services-PA

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