SPL MEDGUIDE

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K)	AMITRIPTYLINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	WHITE (OFF-WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	5mm
Flavor		Imprint Code	ZA;1
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1173-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2017
2	NDC:70771-1173-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K)	AMITRIPTYLINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ALUMINUM OXIDE (UNII: LMI26O6933)

Product Characteristics
Color	GREEN (LIGHT GREEN)	Score	no score
Shape	ROUND (ROUND)	Size	6mm
Flavor		Imprint Code	ZA;2
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1174-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2017
2	NDC:70771-1174-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K)	AMITRIPTYLINE HYDROCHLORIDE	50 mg

Ingredient Name	Strength
Inactive Ingredients
ALUMINUM OXIDE (UNII: LMI26O6933)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BROWN (BROWN)	Score	no score
Shape	ROUND (ROUND)	Size	8mm
Flavor		Imprint Code	ZA;3
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1175-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2017
2	NDC:70771-1175-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K)	AMITRIPTYLINE HYDROCHLORIDE	75 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE (LIGHT BLUE)	Score	no score
Shape	ROUND (ROUND)	Size	11mm
Flavor		Imprint Code	12;28
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1176-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2017
2	NDC:70771-1176-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K)	AMITRIPTYLINE HYDROCHLORIDE	100 mg

Ingredient Name	Strength
Inactive Ingredients
ALUMINUM OXIDE (UNII: LMI26O6933)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE (ORANGE)	Score	no score
Shape	ROUND (ROUND)	Size	11mm
Flavor		Imprint Code	12;29
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1177-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2017
2	NDC:70771-1177-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K)	AMITRIPTYLINE HYDROCHLORIDE	150 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (CREAM TO BEIGE)	Score	no score
Shape	CAPSULE (MODIFIED CAPSULE)	Size	17mm
Flavor		Imprint Code	1230
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1178-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2017
2	NDC:70771-1178-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/26/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA210086	12/26/2017

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1173, 70771-1174, 70771-1175, 70771-1176, 70771-1177, 70771-1178) , MANUFACTURE(70771-1173, 70771-1174, 70771-1175, 70771-1176, 70771-1177, 70771-1178)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		677605858	ANALYSIS(70771-1173, 70771-1174, 70771-1175, 70771-1176, 70771-1177, 70771-1178) , MANUFACTURE(70771-1173, 70771-1174, 70771-1175, 70771-1176, 70771-1177, 70771-1178)

Amitriptyline Hydrochloride Tablets, USP

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL