TADALAFIL - tadalafil tablet, film coated 
Cadila Healthcare Limited

----------

TADALAFIL TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1475-3 in bottle of 30 tablets

Tadalafil Tablets USP, 2.5 mg

Rx Only

30 tablets

2.5 mg label

NDC 70771-1476-3 in bottle of 30 tablets

Tadalafil Tablets USP, 5 mg

Rx Only

30 tablets

5 mg

NDC 70771-1477-3 in bottle of 30 tablets

Tadalafil Tablets USP, 10 mg

Rx Only

30 tablets

10 mg

NDC 70771-1478-3 in bottle of 30 tablets

Tadalafil Tablets USP, 20 mg

Rx Only

30 tablets

20 mg
TADALAFIL 
tadalafil tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1475
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TADALAFIL (UNII: 742SXX0ICT) (TADALAFIL - UNII:742SXX0ICT) TADALAFIL2.5 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorWHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size6mm
FlavorImprint Code T;1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1475-330 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
2NDC:70771-1475-990 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
3NDC:70771-1475-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
4NDC:70771-1475-5500 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
5NDC:70771-1475-01000 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
6NDC:70771-1475-42 in 1 CARTON03/27/2019
615 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20669303/27/2019
TADALAFIL 
tadalafil tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1477
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TADALAFIL (UNII: 742SXX0ICT) (TADALAFIL - UNII:742SXX0ICT) TADALAFIL10 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorYELLOW (YELLOW) Scoreno score
ShapeCAPSULE (CAPSULE) Size10mm
FlavorImprint Code 898
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1477-330 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
2NDC:70771-1477-990 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
3NDC:70771-1477-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
4NDC:70771-1477-5500 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
5NDC:70771-1477-01000 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
6NDC:70771-1477-42 in 1 CARTON03/27/2019
615 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20669303/27/2019
TADALAFIL 
tadalafil tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1478
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TADALAFIL (UNII: 742SXX0ICT) (TADALAFIL - UNII:742SXX0ICT) TADALAFIL20 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorYELLOW (YELLOW) Scoreno score
ShapeOVAL (OVAL) Size13mm
FlavorImprint Code 899
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1478-330 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
2NDC:70771-1478-990 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
3NDC:70771-1478-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
4NDC:70771-1478-5500 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
5NDC:70771-1478-01000 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
6NDC:70771-1478-42 in 1 CARTON03/27/2019
615 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20669303/27/2019
TADALAFIL 
tadalafil tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1476
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TADALAFIL (UNII: 742SXX0ICT) (TADALAFIL - UNII:742SXX0ICT) TADALAFIL5 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorYELLOW (YELLOW) Scoreno score
ShapeOVAL (OVAL) Size8mm
FlavorImprint Code 897
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1476-710 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
2NDC:70771-1476-330 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
3NDC:70771-1476-990 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
4NDC:70771-1476-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
5NDC:70771-1476-5500 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
6NDC:70771-1476-01000 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2019
7NDC:70771-1476-42 in 1 CARTON03/27/2019
715 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20669303/27/2019
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(70771-1475, 70771-1476, 70771-1477, 70771-1478) , MANUFACTURE(70771-1475, 70771-1476, 70771-1477, 70771-1478)

Revised: 10/2020
Document Id: 7aa5d082-9fb8-49da-8073-ebd6f51c2781
Set id: 6c1c3a1f-80a4-417c-8830-5edbb9a0710f
Version: 2
Effective Time: 20201003
 
Cadila Healthcare Limited