NDC Code(s) : 0591-5621-01, 0591-5621-05, 0591-5621-10, 0591-5619-01, 0591-5619-05, 0591-5619-10, 0591-5620-01, 0591-5620-05, 0591-5620-10
Packager : Actavis Pharma, 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:0591-5621
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)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 8 mm
Flavor Imprint Code DAN;5621;2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-5621-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
2NDC:0591-5621-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
3NDC:0591-5621-101000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071134 02/03/1987
DiazepamDiazepam TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-5619
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)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 8 mm
Flavor Imprint Code DAN;5619;5
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-5619-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
2NDC:0591-5619-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
3NDC:0591-5619-101000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071135 02/03/1987
DiazepamDiazepam TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-5620
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)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color BLUE Score 2 pieces
Shape ROUND Size 8 mm
Flavor Imprint Code DAN;5620;10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-5620-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
2NDC:0591-5620-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
3NDC:0591-5620-101000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071136 02/03/1987

PRINCIPAL DISPLAY PANEL

NDC 0591-5621-01
CIV
Diazepam
Tablets, USP
2 mg 
Actavis 100 Tablets Rx only

diazepam 2mg label

PRINCIPAL DISPLAY PANEL

NDC 0591-5619-01
CIV
Diazepam
Tablets, USP
5 mg 
Actavis  100 Tablets Rx only

diazepam 5mg label

PRINCIPAL DISPLAY PANEL

NDC 0591-5620-01
CIV
Diazepam
Tablets, USP
10 mg 
Actavis   100 Tablets  Rx only

diazepam 10 mg