Amitriptyline Hydrochloride (Page 6 of 6)

10 mg Label-India

NDC 0781-1486-01

Amitriptyline HCl

Tablets, USP

10 mg

Rx Only

PHARMACIST: Please dispense

with Medication Guide provided

separately.

100 Tablets

SANDOZ

10mglabel
(click image for full-size original)

25 mg Label-India

NDC 0781-1487-01

Amitriptyline HCl

Tablets, USP

25 mg

Rx Only

PHARMACIST: Please dispense

with Medication Guide provided

separately.

100 Tablets

Sandoz

25mglabel
(click image for full-size original)

50mg Label-India

NDC 0781-1488-01

Amitriptyline HCl

Tablets, USP

50 mg

Rx Only

PHARMACIST: Please dispense

with Medication Guide provided

separately.

100 Tablets

Sandoz

50mglabel
(click image for full-size original)

75mg Label-India

NDC 0781-1489-01

Amitriptyline HCl

Tablets, USP

75 mg

Rx Only

PHARMACIST: Please dispense

with Medication Guide provided

separately.

100 Tablets

Sandoz

75mglabel
(click image for full-size original)

100mg Label-India

NDC 0781-1490-01

Amitriptyline HCl

Tablets, USP

100 mg

Rx Only

PHARMACIST: Please dispense

with Medication Guide provided

separately.

100 Tablets

Sandoz

100mglabel
(click image for full-size original)

150mg Label-India

NDC 0781-1491-01

Amitriptyline HCl

Tablets, USP

150 mg

Rx Only

PHARMACIST: Please dispense

with Medication Guide provided

separately.

100 Tablets

Sandoz

150mglabel
(click image for full-size original)
AMITRIPTYLINE HYDROCHLORIDE
amitriptyline 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 (AMITRIPTYLINE) AMITRIPTYLINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
D&C RED NO. 27
D&C YELLOW NO. 10
FD&C BLUE NO. 1
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color PINK Score no score
Shape ROUND Size 6mm
Flavor Imprint Code GG40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-1486-10 1000 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0781-1486-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:0781-1486-31 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085968 11/21/1977
AMITRIPTYLINE HYDROCHLORIDE
amitriptyline 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 (AMITRIPTYLINE) AMITRIPTYLINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color GREEN (light) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code GG44
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-1487-10 1000 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0781-1487-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:0781-1487-31 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085968 11/21/1977
AMITRIPTYLINE HYDROCHLORIDE
amitriptyline 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 (AMITRIPTYLINE) AMITRIPTYLINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
D&C YELLOW NO. 10
FD&C BLUE NO. 2
FD&C RED NO. 40
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 8mm
Flavor Imprint Code GG431
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-1488-10 1000 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0781-1488-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:0781-1488-31 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085968 11/29/1977
AMITRIPTYLINE HYDROCHLORIDE
amitriptyline 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 (AMITRIPTYLINE) AMITRIPTYLINE HYDROCHLORIDE 75 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
D&C RED NO. 7
FD&C BLUE NO. 2
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color PURPLE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code GG451
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-1489-31 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0781-1489-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:0781-1489-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085968 11/29/1977
AMITRIPTYLINE HYDROCHLORIDE
amitriptyline 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 (AMITRIPTYLINE) AMITRIPTYLINE HYDROCHLORIDE 100 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
D&C RED NO. 30
D&C YELLOW NO. 10
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 11mm
Flavor Imprint Code GG461
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-1490-10 1000 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0781-1490-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:0781-1490-31 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085968 11/21/1977
AMITRIPTYLINE HYDROCHLORIDE
amitriptyline 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 (AMITRIPTYLINE) AMITRIPTYLINE HYDROCHLORIDE 150 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color GREEN (light) Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code GG450
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-1491-10 1000 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0781-1491-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:0781-1491-31 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085968 11/21/1977
Labeler — Sandoz Inc (005387188)

Revised: 03/2024 Sandoz Inc

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