Amitriptyline Hydrochloride

AMITRIPTYLINE HYDROCHLORIDE — amitriptyline hydrochloride tablet, film coated
Zydus Lifesciences Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1173-1 in bottle of 100 Tablets

Amitriptyline Hydrochloride Tablets USP, 10 mg

Rx only

100 Tablets

Amitriptyline Hydrochloride Tablets, USP
(click image for full-size original)

NDC 70771-1174-1 in bottle of 100 Tablets

Amitriptyline Hydrochloride Tablets USP, 25 mg

Rx only

100 Tablets

Amitriptyline Hydrochloride Tablets, USP
(click image for full-size original)

NDC 70771-1175-1 in bottle of 100 Tablets

Amitriptyline Hydrochloride Tablets USP, 50 mg

Rx only

100 Tablets

Amitriptyline Hydrochloride Tablets, USP
(click image for full-size original)

NDC 70771-1176-1 in bottle of 100 Tablets

Amitriptyline Hydrochloride Tablets USP, 75 mg

Rx only

100 Tablets

Amitriptyline Hydrochloride Tablets, USP
(click image for full-size original)

NDC 70771-1177-1 in bottle of 100 Tablets

Amitriptyline Hydrochloride Tablets USP, 100 mg

Rx only

100 Tablets

Amitriptyline Hydrochloride Tablets, USP
(click image for full-size original)

NDC 70771-1178-1 in bottle of 100 Tablets

Amitriptyline Hydrochloride Tablets USP, 150 mg

Rx only

100 Tablets

Amitriptyline Hydrochloride Tablets, USP
(click image for full-size original)
AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1173
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
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 8000
TITANIUM DIOXIDE
TALC
Product Characteristics
Color WHITE (OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 5mm
Flavor Imprint Code ZA;1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1173-1 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1173-0 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210086 12/26/2017
AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1174
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
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 8000
TITANIUM DIOXIDE
TALC
FD&C BLUE NO. 1
D&C YELLOW NO. 10
ALUMINUM OXIDE
Product Characteristics
Color GREEN (LIGHT GREEN) Score no score
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code ZA;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1174-1 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1174-0 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210086 12/26/2017
AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1175
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
ALUMINUM OXIDE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 8000
SILICON DIOXIDE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color BROWN (BROWN) Score no score
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code ZA;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1175-1 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1175-0 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210086 12/26/2017
AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1176
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
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
FERRIC OXIDE YELLOW
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 8000
SILICON DIOXIDE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color BLUE (LIGHT BLUE) Score no score
Shape ROUND (ROUND) Size 11mm
Flavor Imprint Code 12;28
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1176-1 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1176-0 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210086 12/26/2017
AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1177
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
ALUMINUM OXIDE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
D&C RED NO. 27
D&C YELLOW NO. 10
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 8000
SILICON DIOXIDE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color ORANGE (ORANGE) Score no score
Shape ROUND (ROUND) Size 11mm
Flavor Imprint Code 12;29
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1177-1 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1177-0 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210086 12/26/2017
AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1178
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
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 8000
SILICON DIOXIDE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (CREAM TO BEIGE) Score no score
Shape CAPSULE (MODIFIED CAPSULE) Size 17mm
Flavor Imprint Code 1230
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1178-1 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1178-0 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210086 12/26/2017
Labeler — Zydus Lifesciences Limited (918596198)
Registrant — Zydus Lifesciences Limited (918596198)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 863362789 ANALYSIS (70771-1173), ANALYSIS (70771-1174), ANALYSIS (70771-1175), ANALYSIS (70771-1176), ANALYSIS (70771-1177), ANALYSIS (70771-1178), MANUFACTURE (70771-1173), MANUFACTURE (70771-1174), MANUFACTURE (70771-1175), MANUFACTURE (70771-1176), MANUFACTURE (70771-1177), MANUFACTURE (70771-1178)

Revised: 08/2022 Zydus Lifesciences Limited

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