NDC Code(s) : 0781-1486-10, 0781-1486-01, 0781-1486-31, 0781-1487-10, 0781-1487-01, 0781-1487-31, 0781-1488-10, 0781-1488-01, 0781-1488-31, 0781-1489-31, 0781-1489-01, 0781-1489-10, 0781-1490-10, 0781-1490-01, 0781-1490-31, 0781-1491-10, 0781-1491-01, 0781-1491-31
Packager : Sandoz Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Amitriptyline HydrochlorideAmitriptyline Hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-1486
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMITRIPTYLINE HYDROCHLORIDE(UNII: 26LUD4JO9K)
(AMITRIPTYLINE - UNII:1806D8D52K) 		AMITRIPTYLINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
D&C RED NO. 27(UNII: 2LRS185U6K)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color PINK Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code GG40
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-1486-101000 in 1 BOTTLE Type 0: Not a Combination Product21/11/1977
2NDC:0781-1486-01100 in 1 BOTTLE Type 0: Not a Combination Product21/11/1977
3NDC:0781-1486-3130 in 1 BOTTLE Type 0: Not a Combination Product21/11/1977
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085968 11/21/1977
Amitriptyline HydrochlorideAmitriptyline Hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-1487
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMITRIPTYLINE HYDROCHLORIDE(UNII: 26LUD4JO9K)
(AMITRIPTYLINE - UNII:1806D8D52K) 		AMITRIPTYLINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color GREEN (light) Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code GG44
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-1487-101000 in 1 BOTTLE Type 0: Not a Combination Product21/11/1977
2NDC:0781-1487-01100 in 1 BOTTLE Type 0: Not a Combination Product21/11/1977
3NDC:0781-1487-3130 in 1 BOTTLE Type 0: Not a Combination Product21/11/1977
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085968 11/21/1977
Amitriptyline HydrochlorideAmitriptyline Hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-1488
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMITRIPTYLINE HYDROCHLORIDE(UNII: 26LUD4JO9K)
(AMITRIPTYLINE - UNII:1806D8D52K) 		AMITRIPTYLINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code GG431
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-1488-101000 in 1 BOTTLE Type 0: Not a Combination Product29/11/1977
2NDC:0781-1488-01100 in 1 BOTTLE Type 0: Not a Combination Product29/11/1977
3NDC:0781-1488-3130 in 1 BOTTLE Type 0: Not a Combination Product29/11/1977
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085968 11/29/1977
Amitriptyline HydrochlorideAmitriptyline Hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-1489
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMITRIPTYLINE HYDROCHLORIDE(UNII: 26LUD4JO9K)
(AMITRIPTYLINE - UNII:1806D8D52K) 		AMITRIPTYLINE HYDROCHLORIDE75 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
D&C RED NO. 7(UNII: ECW0LZ41X8)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color PURPLE Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code GG451
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-1489-3130 in 1 BOTTLE Type 0: Not a Combination Product29/11/1977
2NDC:0781-1489-01100 in 1 BOTTLE Type 0: Not a Combination Product29/11/1977
3NDC:0781-1489-101000 in 1 BOTTLE Type 0: Not a Combination Product29/11/1977
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085968 11/29/1977
Amitriptyline HydrochlorideAmitriptyline Hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-1490
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMITRIPTYLINE HYDROCHLORIDE(UNII: 26LUD4JO9K)
(AMITRIPTYLINE - UNII:1806D8D52K) 		AMITRIPTYLINE HYDROCHLORIDE100 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
D&C RED NO. 30(UNII: 2S42T2808B)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 11 mm
Flavor Imprint Code GG461
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-1490-101000 in 1 BOTTLE Type 0: Not a Combination Product21/11/1977
2NDC:0781-1490-01100 in 1 BOTTLE Type 0: Not a Combination Product21/11/1977
3NDC:0781-1490-3130 in 1 BOTTLE Type 0: Not a Combination Product21/11/1977
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085968 11/21/1977
Amitriptyline HydrochlorideAmitriptyline Hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-1491
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMITRIPTYLINE HYDROCHLORIDE(UNII: 26LUD4JO9K)
(AMITRIPTYLINE - UNII:1806D8D52K) 		AMITRIPTYLINE HYDROCHLORIDE150 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color GREEN (light) Score no score
Shape CAPSULE Size 17 mm
Flavor Imprint Code GG450
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-1491-101000 in 1 BOTTLE Type 0: Not a Combination Product21/11/1977
2NDC:0781-1491-01100 in 1 BOTTLE Type 0: Not a Combination Product21/11/1977
3NDC:0781-1491-3130 in 1 BOTTLE Type 0: Not a Combination Product21/11/1977
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085968 11/21/1977

LABELER - Sandoz Inc(005387188)

PRINCIPAL DISPLAY PANEL

NDC 0781-1486-01

Amitriptyline HCl

Tablets, USP

10 mg

Rx Only

PHARMACIST: Please dispense

with Medication Guide provided

separately.

100 Tablets

SANDOZ

10mglabel

PRINCIPAL DISPLAY PANEL

NDC 0781-1487-01

Amitriptyline HCl

Tablets, USP

25 mg

Rx Only

PHARMACIST: Please dispense

with Medication Guide provided

separately.

100 Tablets

Sandoz

25mglabel

PRINCIPAL DISPLAY PANEL

NDC 0781-1488-01

Amitriptyline HCl

Tablets, USP

50 mg

Rx Only

PHARMACIST: Please dispense

with Medication Guide provided

separately.

100 Tablets

Sandoz

50mglabel

PRINCIPAL DISPLAY PANEL

NDC 0781-1489-01

Amitriptyline HCl

Tablets, USP

75 mg

Rx Only

PHARMACIST: Please dispense

with Medication Guide provided

separately.

100 Tablets

Sandoz

75mglabel

PRINCIPAL DISPLAY PANEL

NDC 0781-1490-01

Amitriptyline HCl

Tablets, USP

100 mg

Rx Only

PHARMACIST: Please dispense

with Medication Guide provided

separately.

100 Tablets

Sandoz

100mglabel

PRINCIPAL DISPLAY PANEL

NDC 0781-1491-01

Amitriptyline HCl

Tablets, USP

150 mg

Rx Only

PHARMACIST: Please dispense

with Medication Guide provided

separately.

100 Tablets

Sandoz

150mglabel