Diazepam: Package Insert and Label Information (Page 3 of 3)

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NDC 43063 -987- 20

Diazepam
Tablets USP

CIV


10 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

DIAZEPAM
diazepam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-987(NDC:0172-3927)
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
SILICON DIOXIDE
FD&C BLUE NO. 1
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color blue (light blue) Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code 3927;TEVA
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43063-987-20 20 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:43063-987-30 30 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:43063-987-60 60 TABLET in 1 BOTTLE, PLASTIC None
4 NDC:43063-987-02 2 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071322 12/10/1986
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (43063-987)

Revised: 09/2020 PD-Rx Pharmaceuticals, Inc.

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