NDC Code(s) : 0172-3925-60, 0172-3925-70, 0172-3926-60, 0172-3926-70, 0172-3926-80, 0172-3927-60, 0172-3927-70, 0172-3927-80
Packager : Teva Pharmaceuticals USA, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DiazepamDiazepam TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0172-3925
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIAZEPAM(UNII: Q3JTX2Q7TU)
(DIAZEPAM - UNII:Q3JTX2Q7TU) 		DIAZEPAM2 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 8 mm
Flavor Imprint Code 3925;TEVA
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0172-3925-60100 in 1 BOTTLE Type 0: Not a Combination Product12/10/1986
2NDC:0172-3925-70500 in 1 BOTTLE Type 0: Not a Combination Product18/10/2000
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071307 12/10/1986
DiazepamDiazepam TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0172-3926
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIAZEPAM(UNII: Q3JTX2Q7TU)
(DIAZEPAM - UNII:Q3JTX2Q7TU) 		DIAZEPAM5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
D&C YELLOW NO. 10 ALUMINUM LAKE(UNII: CQ3XH3DET6)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color yellow Score 2 pieces
Shape ROUND Size 8 mm
Flavor Imprint Code 3926;TEVA
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0172-3926-60100 in 1 BOTTLE Type 0: Not a Combination Product12/10/1986
2NDC:0172-3926-70500 in 1 BOTTLE Type 0: Not a Combination Product12/10/1986
3NDC:0172-3926-801000 in 1 BOTTLE Type 0: Not a Combination Product12/10/1986
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071321 12/10/1986
DiazepamDiazepam TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0172-3927
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIAZEPAM(UNII: Q3JTX2Q7TU)
(DIAZEPAM - UNII:Q3JTX2Q7TU) 		DIAZEPAM10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C BLUE NO. 1 ALUMINUM LAKE(UNII: J9EQA3S2JM)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color blue (light blue) Score 2 pieces
Shape ROUND Size 8 mm
Flavor Imprint Code 3927;TEVA
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0172-3927-60100 in 1 BOTTLE Type 0: Not a Combination Product12/10/1986
2NDC:0172-3927-70500 in 1 BOTTLE Type 0: Not a Combination Product12/10/1986
3NDC:0172-3927-801000 in 1 BOTTLE Type 0: Not a Combination Product12/10/1986
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071322 12/10/1986

LABELER - Teva Pharmaceuticals USA, Inc.(001627975)

PRINCIPAL DISPLAY PANEL

NDC 0172-3925-60

Diazepam Tablets, USP   CIV

2 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

100 Tablets 

image

PRINCIPAL DISPLAY PANEL

NDC 0172-3926-60

Diazepam Tablets USP    CIV

5 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

100 Tablets

Image

PRINCIPAL DISPLAY PANEL

NDC 0172-3927-60

Diazepam Tablets USP    CIV

10 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

100 Tablets

  Image