Amitriptyline Hydrochloride (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel — 10 mg Tablets: Container Label

NDC 69844-058-01

Amitriptyline Hydrochloride Tablets, USP

Rx only

30 Tablets

Manufactured for Graviti Pharmaceuticals Inc.

Made in India.

image
(click image for full-size original)

Principal Display Panel — 25 mg Tablets: Container Label

NDC 69844-059-01

Amitriptyline Hydrochloride Tablets, USP

Rx only

30 Tablets

Manufactured for Graviti Pharmaceuticals Inc.

Made in India.

image
(click image for full-size original)

Principal Display Panel — 50 mg Tablets: Container Label

NDC 69844-060-01

Amitriptyline Hydrochloride Tablets, USP

Rx only

30 Tablets

Manufactured for Graviti Pharmaceuticals Inc.

Made in India.

image
(click image for full-size original)

Principal Display Panel — 75 mg Tablets: Container Label

NDC 69844-061-01

Amitriptyline Hydrochloride Tablets, USP

Rx only

30 Tablets

Manufactured for Graviti Pharmaceuticals Inc.

Made in India.

image
(click image for full-size original)

Principal Display Panel — 100 mg Tablets: Container Label

NDC 69844-062-01

Amitriptyline Hydrochloride Tablets, USP

Rx only

30 Tablets

Manufactured for Graviti Pharmaceuticals Inc.

Made in India.

image
(click image for full-size original)

Principal Display Panel — 150 mg Tablets: Container Label

NDC 69844-063-01

Amitriptyline Hydrochloride Tablets, USP

Rx only

30 Tablets

Manufactured for Graviti Pharmaceuticals Inc.

Made in India.

image
(click image for full-size original)
AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69844-058
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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE (90000 WAMW)
ISOPROPYL ALCOHOL
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 101
MICROCRYSTALLINE CELLULOSE 102
STARCH, CORN
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 8000
TITANIUM DIOXIDE
CARMINIC ACID
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
Product Characteristics
Color PINK Score no score
Shape ROUND Size 5mm
Flavor Imprint Code 1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69844-058-01 30 TABLET in 1 BOTTLE None
2 NDC:69844-058-02 100 TABLET in 1 BOTTLE None
3 NDC:69844-058-03 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA217411 05/26/2023
AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69844-059
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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE (90000 WAMW)
ISOPROPYL ALCOHOL
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 101
MICROCRYSTALLINE CELLULOSE 102
STARCH, CORN
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 8000
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
Product Characteristics
Color GREEN (Light green) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 31
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69844-059-01 30 TABLET in 1 BOTTLE None
2 NDC:69844-059-02 100 TABLET in 1 BOTTLE None
3 NDC:69844-059-03 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA217411 05/26/2023
AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69844-060
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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE (90000 WAMW)
ISOPROPYL ALCOHOL
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 101
MICROCRYSTALLINE CELLULOSE 102
STARCH, CORN
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 8000
TITANIUM DIOXIDE
FD&C BLUE NO. 2
FD&C RED NO. 40
FERRIC OXIDE RED
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 32
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69844-060-01 30 TABLET in 1 BOTTLE None
2 NDC:69844-060-02 100 TABLET in 1 BOTTLE None
3 NDC:69844-060-03 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA217411 05/26/2023
AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69844-061
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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE (90000 WAMW)
ISOPROPYL ALCOHOL
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 101
MICROCRYSTALLINE CELLULOSE 102
STARCH, CORN
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 8000
TITANIUM DIOXIDE
CARMINIC ACID
FD&C BLUE NO. 2
FERROSOFERRIC OXIDE
Product Characteristics
Color PURPLE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 45
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69844-061-01 30 TABLET in 1 BOTTLE None
2 NDC:69844-061-02 100 TABLET in 1 BOTTLE None
3 NDC:69844-061-03 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA217411 05/26/2023
AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69844-062
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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE (90000 WAMW)
ISOPROPYL ALCOHOL
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 101
MICROCRYSTALLINE CELLULOSE 102
STARCH, CORN
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 8000
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
FERRIC OXIDE RED
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 11mm
Flavor Imprint Code 46
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69844-062-01 30 TABLET in 1 BOTTLE None
2 NDC:69844-062-02 100 TABLET in 1 BOTTLE None
3 NDC:69844-062-03 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA217411 05/26/2023
AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69844-063
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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE (90000 WAMW)
ISOPROPYL ALCOHOL
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 101
MICROCRYSTALLINE CELLULOSE 102
STARCH, CORN
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 8000
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
FERRIC OXIDE YELLOW
Product Characteristics
Color GREEN (Light green) Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code 47
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69844-063-01 30 TABLET in 1 BOTTLE None
2 NDC:69844-063-02 100 TABLET in 1 BOTTLE None
3 NDC:69844-063-03 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA217411 05/26/2023
Labeler — Graviti Pharmaceuticals Private Limited (650884781)
Registrant — Graviti Pharmaceuticals Private Limited (650884781)
Establishment
Name Address ID/FEI Operations
Graviti Pharmaceuticals Private Limited 650884781 MANUFACTURE (69844-058), MANUFACTURE (69844-059), MANUFACTURE (69844-060), MANUFACTURE (69844-061), MANUFACTURE (69844-062), MANUFACTURE (69844-063), ANALYSIS (69844-058), ANALYSIS (69844-059), ANALYSIS (69844-060), ANALYSIS (69844-061), ANALYSIS (69844-062), ANALYSIS (69844-063)

Revised: 05/2023 Graviti Pharmaceuticals Private Limited

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