NDC Code(s) : 0093-3016-30, 0093-3016-65, 0093-3017-30, 0093-3017-65, 0093-3017-56, 0093-3018-56, 0093-3019-56
Packager : Teva Pharmaceuticals USA, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TadalafilTadalafil TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-3016
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TADALAFIL(UNII: 742SXX0ICT)
(TADALAFIL - UNII:742SXX0ICT) 		TADALAFIL2.5 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
POLYVINYL ALCOHOL (100000 MW)(UNII: 949E52Z6MY)
POVIDONE K30(UNII: U725QWY32X)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color yellow (light yellow) Score no score
Shape ROUND Size 5 mm
Flavor Imprint Code TEVA;3016
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-3016-652 in 1 BOX 27/09/2018
1NDC:0093-3016-3015 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090141 09/27/2018
TadalafilTadalafil TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-3017
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TADALAFIL(UNII: 742SXX0ICT)
(TADALAFIL - UNII:742SXX0ICT) 		TADALAFIL5 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
POLYVINYL ALCOHOL (100000 MW)(UNII: 949E52Z6MY)
POVIDONE K30(UNII: U725QWY32X)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color yellow Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code TEVA;3017
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-3017-652 in 1 BOX 27/09/2018
1NDC:0093-3017-3015 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:0093-3017-5630 in 1 BOTTLE Type 0: Not a Combination Product27/09/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090141 09/27/2018
TadalafilTadalafil TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-3018
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TADALAFIL(UNII: 742SXX0ICT)
(TADALAFIL - UNII:742SXX0ICT) 		TADALAFIL10 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
POLYVINYL ALCOHOL (100000 MW)(UNII: 949E52Z6MY)
POVIDONE K30(UNII: U725QWY32X)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color yellow Score no score
Shape OVAL Size 11 mm
Flavor Imprint Code TEVA;3018
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-3018-5630 in 1 BOTTLE Type 0: Not a Combination Product27/09/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090141 09/27/2018
TadalafilTadalafil TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-3019
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TADALAFIL(UNII: 742SXX0ICT)
(TADALAFIL - UNII:742SXX0ICT) 		TADALAFIL20 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
POLYVINYL ALCOHOL (100000 MW)(UNII: 949E52Z6MY)
POVIDONE K30(UNII: U725QWY32X)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color yellow Score no score
Shape OVAL Size 14 mm
Flavor Imprint Code TEVA;3019
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-3019-5630 in 1 BOTTLE Type 0: Not a Combination Product27/09/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090141 09/27/2018

LABELER - Teva Pharmaceuticals USA, Inc.(001627975)

PRINCIPAL DISPLAY PANEL

NDC 0093-3016-56

Tadalafil  Tablets USP

2.5 mg

for once daily use

Rx only

30 TABLETS (2 cards of 15 tablets)

TEVA

1

PRINCIPAL DISPLAY PANEL

NDC 0093-3017-56

Tadalafil 
 Tablets USP

5 mg

Tablets should not be split.

Entire dose should be taken.

Rx only

30 TABLETS

TEVA

image

PRINCIPAL DISPLAY PANEL

NDC 0093-3018-56

Tadalafil 
 Tablets USP

10 mg

Tablets should not be split.

Entire dose should be taken.

Rx only

30 TABLETS

TEVA


image

PRINCIPAL DISPLAY PANEL

NDC 0093-3019-56

Tadalafil 
 Tablets USP

20 mg

Tablets should not be split.

Entire dose should be taken.

Rx only

30 TABLETS

TEVA

1