Amitriptyline Hydrochloride (Page 6 of 6)

10 mg Label

10mgx100.JPG
(click image for full-size original)

Rx only

NDC 16714-446-01

Amitriptyline HCl

Tablets, USP

10 mg

PHARMACIST: Please dispense with

Medication Guide provided separately.

100 Tablets

NorthStar

25 mg Label

25mgx100.JPG
(click image for full-size original)

Rx only

NDC 16714-447-01

Amitriptyline HCl

Tablets, USP

25 mg

PHARMACIST: Please dispense with

Medication Guide provided separately.

100 Tablets

NorthStar

50 mg Label

50mgx100.JPG
(click image for full-size original)

Rx only

NDC 16714-448-01

Amitriptyline HCl

Tablets, USP

50 mg

PHARMACIST: Please dispense with

Medication Guide provided separately.

100 Tablets

NorthStar

75 mg Label

75mgx100.JPG
(click image for full-size original)

Rx only

NDC 16714-449-01

Amitriptyline HCl

Tablets, USP

75 mg

PHARMACIST: Please dispense with

Medication Guide provided separately.

100 Tablets

NorthStar

100 mg Label

100mgx100.JPG
(click image for full-size original)

Rx only

NDC 16714-450-01

Amitriptyline HCl

Tablets, USP

100 mg

PHARMACIST: Please dispense with

Medication Guide provided separately.

100 Tablets

NorthStar

150 mg Label

150mgx100.JPG
(click image for full-size original)

Rx only

NDC 16714-451-01

Amitriptyline HCl

Tablets, USP

150 mg

PHARMACIST: Please dispense with

Medication Guide provided separately.

100 Tablets

NorthStar

AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-446
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:16714-446-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:16714-446-02 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085969 12/01/2014
AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-447
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:16714-447-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:16714-447-02 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085966 12/01/2014
AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-448
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:16714-448-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:16714-448-02 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 12/01/2014
AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-449
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:16714-449-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085971 12/01/2014
AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-450
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:16714-450-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085967 12/01/2014
AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-451
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:16714-451-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085970 12/01/2014
Labeler — Northstar RxLLC (830546433)

Revised: 08/2020 Northstar RxLLC

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