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

NDC 70771-1174-1 in bottle of 100 Tablets

Amitriptyline Hydrochloride Tablets USP, 25 mg

Rx only

100 Tablets

NDC 70771-1175-1 in bottle of 100 Tablets

Amitriptyline Hydrochloride Tablets USP, 50 mg

Rx only

100 Tablets

NDC 70771-1176-1 in bottle of 100 Tablets

Amitriptyline Hydrochloride Tablets USP, 75 mg

Rx only

100 Tablets

NDC 70771-1177-1 in bottle of 100 Tablets

Amitriptyline Hydrochloride Tablets USP, 100 mg

Rx only

100 Tablets

NDC 70771-1178-1 in bottle of 100 Tablets

Amitriptyline Hydrochloride Tablets USP, 150 mg

Rx only

100 Tablets

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