AMITRIPTYLINE HYDROCHLORIDE- amitriptyline hydrochloride tablet, film coated 
Cadila Healthcare Limited

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Amitriptyline Hydrochloride Tablets, USP

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

NDC 70771-1174-1 in bottle of 100 Tablets

Amitriptyline Hydrochloride Tablets USP, 25 mg

Rx only

100 Tablets

Amitriptyline Hydrochloride Tablets, USP

NDC 70771-1175-1 in bottle of 100 Tablets

Amitriptyline Hydrochloride Tablets USP, 50 mg

Rx only

100 Tablets

Amitriptyline Hydrochloride Tablets, USP

NDC 70771-1176-1 in bottle of 100 Tablets

Amitriptyline Hydrochloride Tablets USP, 75 mg

Rx only

100 Tablets

Amitriptyline Hydrochloride Tablets, USP

NDC 70771-1177-1 in bottle of 100 Tablets

Amitriptyline Hydrochloride Tablets USP, 100 mg

Rx only

100 Tablets

Amitriptyline Hydrochloride Tablets, USP

NDC 70771-1178-1 in bottle of 100 Tablets

Amitriptyline Hydrochloride Tablets USP, 150 mg

Rx only

100 Tablets

Amitriptyline Hydrochloride Tablets, USP
AMITRIPTYLINE HYDROCHLORIDE 
amitriptyline hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1173
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K) AMITRIPTYLINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size5mm
FlavorImprint Code ZA;1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1173-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2017
2NDC:70771-1173-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21008612/26/2017
AMITRIPTYLINE HYDROCHLORIDE 
amitriptyline hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1174
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K) AMITRIPTYLINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorGREEN (LIGHT GREEN) Scoreno score
ShapeROUND (ROUND) Size6mm
FlavorImprint Code ZA;2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1174-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2017
2NDC:70771-1174-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21008612/26/2017
AMITRIPTYLINE HYDROCHLORIDE 
amitriptyline hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1175
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K) AMITRIPTYLINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorBROWN (BROWN) Scoreno score
ShapeROUND (ROUND) Size8mm
FlavorImprint Code ZA;3
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1175-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2017
2NDC:70771-1175-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21008612/26/2017
AMITRIPTYLINE HYDROCHLORIDE 
amitriptyline hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1176
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K) AMITRIPTYLINE HYDROCHLORIDE75 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorBLUE (LIGHT BLUE) Scoreno score
ShapeROUND (ROUND) Size11mm
FlavorImprint Code 12;28
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1176-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2017
2NDC:70771-1176-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21008612/26/2017
AMITRIPTYLINE HYDROCHLORIDE 
amitriptyline hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1177
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K) AMITRIPTYLINE HYDROCHLORIDE100 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorORANGE (ORANGE) Scoreno score
ShapeROUND (ROUND) Size11mm
FlavorImprint Code 12;29
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1177-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2017
2NDC:70771-1177-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21008612/26/2017
AMITRIPTYLINE HYDROCHLORIDE 
amitriptyline hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1178
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K) AMITRIPTYLINE HYDROCHLORIDE150 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (CREAM TO BEIGE) Scoreno score
ShapeCAPSULE (MODIFIED CAPSULE) Size17mm
FlavorImprint Code 1230
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1178-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2017
2NDC:70771-1178-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21008612/26/2017
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited863362789ANALYSIS(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)

Revised: 8/2020
Document Id: 10ed7b73-a8fb-4d79-91af-dc0379b8f8f4
Set id: 4159b10e-f589-486c-969d-9b4544b098b5
Version: 3
Effective Time: 20200813
 
Cadila Healthcare Limited