NDC Code(s) : 43547-047-03, 43547-047-50, 43547-049-03, 43547-049-50, 43547-050-03, 43547-050-50, 43547-051-03, 43547-051-50
Packager : Solco Healthcare US, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TADALAFILtadalafil TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43547-047
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)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
Product Characteristics
Color YELLOW Score no score
Shape OVAL (almond) Size 9 mm
Flavor Imprint Code 047
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43547-047-0330 in 1 BOTTLE Type 0: Not a Combination Product18/01/2022
2NDC:43547-047-50500 in 1 BOTTLE Type 0: Not a Combination Product18/01/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210609 01/18/2022
TADALAFILtadalafil TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43547-049
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)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
Product Characteristics
Color YELLOW Score no score
Shape OVAL (almond) Size 10 mm
Flavor Imprint Code 049
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43547-049-0330 in 1 BOTTLE Type 0: Not a Combination Product18/01/2022
2NDC:43547-049-50500 in 1 BOTTLE Type 0: Not a Combination Product18/01/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210609 01/18/2022
TADALAFILtadalafil TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43547-050
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)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
Product Characteristics
Color YELLOW Score no score
Shape OVAL (almond) Size 11 mm
Flavor Imprint Code 050
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43547-050-0330 in 1 BOTTLE Type 0: Not a Combination Product18/01/2022
2NDC:43547-050-50500 in 1 BOTTLE Type 0: Not a Combination Product18/01/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210609 01/18/2022
TADALAFILtadalafil TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43547-051
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)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
Product Characteristics
Color YELLOW Score no score
Shape OVAL (almond) Size 12 mm
Flavor Imprint Code 051
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43547-051-0330 in 1 BOTTLE Type 0: Not a Combination Product18/01/2022
2NDC:43547-051-50500 in 1 BOTTLE Type 0: Not a Combination Product18/01/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210609 01/18/2022

LABELER - Solco Healthcare US, LLC(828343017)

REGISTRANT - Prinston Pharmaceutical Inc.(967289799)

Establishment
Name Address ID/FEI Business Operations
Zhejiang Huahai Pharmaceutical Co., LTD 530732460 MANUFACTURE(43547-047, 43547-049, 43547-050, 43547-051)

PRINCIPAL DISPLAY PANEL

Container Label-2.5 mg-30 tablets

Rx only

NDC 43547-047-03

Tadalafil tablets, USP

Tablets should not be split.

Entire dose should be taken.

Usual Dosage: See accompanying literature for dosage.

Each tablet contains 2.5 mg of tadalafil, USP.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Warning: Keep out of reach of children.

Dispense in a tight container.

Print Patient Information at: www.solcohealthcare.com/medguide/tadalafil-tablets-4.pdf

Manufactured by:

Zhejiang Huahai Pharmaceutical Co., Ltd.

Xunqiao, Linhai, Zhejiang 317024, China

Distributed by:

Solco Healthcare US, LLC

Somerset, NJ 08873, USA

Revised.: 01/2022

2.5 mg

Container Label-5 mg-30 tablets

Rx only

NDC 43547-049-03

Tadalafil tablets, USP

Tablets should not be split.

Entire dose should be taken.

Usual Dosage: See accompanying literature for dosage.

Each tablet contains 5 mg of tadalafil, USP.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Warning: Keep out of reach of children.

Dispense in a tight container.

Print Patient Information at: www.solcohealthcare.com/medguide/tadalafil-tablets-4.pdf

Manufactured by:

Zhejiang Huahai Pharmaceutical Co., Ltd.

Xunqiao, Linhai, Zhejiang 317024, China

Distributed by:

Solco Healthcare US, LLC

Somerset, NJ 08873, USA

Revised.: 01/2022

2.5 mg

Container Label-10 mg-30 tablets

Rx only

NDC 43547-050-03

Tadalafil tablets, USP

Tablets should not be split.

Entire dose should be taken.

Usual Dosage: See accompanying literature for dosage.

Each tablet contains 10 mg of tadalafil, USP.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Warning: Keep out of reach of children.

Dispense in a tight container.

Print Patient Information at: www.solcohealthcare.com/medguide/tadalafil-tablets-4.pdf

Manufactured by:

Zhejiang Huahai Pharmaceutical Co., Ltd.

Xunqiao, Linhai, Zhejiang 317024, China

Distributed by:

Solco Healthcare US, LLC

Somerset, NJ 08873, USA

Revised.: 01/2022

2.5 mg

Container Label-20 mg-30 tablets

Rx only

NDC 43547-51-03

Tadalafil tablets, USP

Tablets should not be split.

Entire dose should be taken.

Usual Dosage: See accompanying literature for dosage.

Each tablet contains 20 mg of tadalafil, USP.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Warning: Keep out of reach of children.

Dispense in a tight container.

Print Patient Information at: www.solcohealthcare.com/medguide/tadalafil-tablets-4.pdf

Manufactured by:

Zhejiang Huahai Pharmaceutical Co., Ltd.

Xunqiao, Linhai, Zhejiang 317024, China

Distributed by:

Solco Healthcare US, LLC

Somerset, NJ 08873, USA

Revised.: 01/2022

2.5 mg