NDC Code(s) : 43547-524-03, 43547-524-09, 43547-524-50, 43547-525-03, 43547-525-09, 43547-525-50, 43547-526-03, 43547-526-09, 43547-526-50, 43547-527-03, 43547-527-09, 43547-527-50
Packager : Solco Healthcare US, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NEBIVOLOLnebivolol TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43547-524
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEBIVOLOL(UNII: 030Y90569U)
(NEBIVOLOL - UNII:030Y90569U) 		NEBIVOLOL2.5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFOACETATE(UNII: D0Y70F2B9J)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color BLUE Score no score
Shape TRIANGLE Size 8 mm
Flavor Imprint Code 671;s
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43547-524-0330 in 1 BOTTLE Type 0: Not a Combination Product14/02/2022
2NDC:43547-524-0990 in 1 BOTTLE Type 0: Not a Combination Product14/02/2022
3NDC:43547-524-50500 in 1 BOTTLE Type 0: Not a Combination Product14/02/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212682 02/14/2022
NEBIVOLOLnebivolol TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43547-525
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEBIVOLOL(UNII: 030Y90569U)
(NEBIVOLOL - UNII:030Y90569U) 		NEBIVOLOL5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFOACETATE(UNII: D0Y70F2B9J)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color YELLOW Score no score
Shape TRIANGLE Size 10 mm
Flavor Imprint Code 672;s
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43547-525-0330 in 1 BOTTLE Type 0: Not a Combination Product14/02/2022
2NDC:43547-525-0990 in 1 BOTTLE Type 0: Not a Combination Product14/02/2022
3NDC:43547-525-50500 in 1 BOTTLE Type 0: Not a Combination Product14/02/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212682 02/14/2022
NEBIVOLOLnebibolol TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43547-526
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEBIVOLOL(UNII: 030Y90569U)
(NEBIVOLOL - UNII:030Y90569U) 		NEBIVOLOL10 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
D&C RED NO. 27(UNII: 2LRS185U6K)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFOACETATE(UNII: D0Y70F2B9J)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color PINK Score no score
Shape TRIANGLE Size 10 mm
Flavor Imprint Code 673;s
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43547-526-0330 in 1 BOTTLE Type 0: Not a Combination Product14/02/2022
2NDC:43547-526-0990 in 1 BOTTLE Type 0: Not a Combination Product14/02/2022
3NDC:43547-526-50500 in 1 BOTTLE Type 0: Not a Combination Product14/02/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212682 02/14/2022
NEBIVOLOLnebivolol TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43547-527
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEBIVOLOL(UNII: 030Y90569U)
(NEBIVOLOL - UNII:030Y90569U) 		NEBIVOLOL20 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color BLUE Score no score
Shape TRIANGLE Size 10 mm
Flavor Imprint Code 674;s
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43547-527-0330 in 1 BOTTLE Type 0: Not a Combination Product14/02/2022
2NDC:43547-527-0990 in 1 BOTTLE Type 0: Not a Combination Product14/02/2022
3NDC:43547-527-50500 in 1 BOTTLE Type 0: Not a Combination Product14/02/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212682 02/14/2022

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(43547-524, 43547-525, 43547-526, 43547-527)

PRINCIPAL DISPLAY PANEL

Container Label-2.5 mg-30 tablets

Rx only

NDC 43547-524-03

Nebivolol Tablets

Each tablet contains: nebivolol hydrochloride equivalent to 2.5 mg nebivolol.

This package is child-resistant. Keep this and all drugs out of the reach of children.

Dispense in tight, light-resistant container as defined in the USP, using a child-resistant closure.

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

See package insert for dosing and full Prescribing Information.

Manufactured by:

Zhejiang Huahai Pharmaceutical Co., Ltd.

Xunqiao, Linhai, Zhejiang 317024, China

Distributed by:

Solco Healthcare US, LLC

Somerset, NJ 08873, USA

Rev.: 02/2022

2.5 mg 30 tablets

PRINCIPAL DISPLAY PANEL

Container Label-5 mg-30 tablets

Rx only

NDC 43547-525-03

Nebivolol Tablets

Each tablet contains: nebivolol hydrochloride equivalent to 5 mg nebivolol.

This package is child-resistant. Keep this and all drugs out of the reach of children.

Dispense in tight, light-resistant container as defined in the USP, using a child-resistant closure.

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

See package insert for dosing and full Prescribing Information.

Manufactured by:

Zhejiang Huahai Pharmaceutical Co., Ltd.

Xunqiao, Linhai, Zhejiang 317024, China

Distributed by:

Solco Healthcare US, LLC

Somerset, NJ 08873, USA

Rev.: 02/2022

5 mg 30 tablets

PRINCIPAL DISPLAY PANEL

Container Label-10 mg-30 tablets

Rx only

NDC 43547-526-03

Nebivolol Tablets

Each tablet contains: nebivolol hydrochloride equivalent to 10 mg nebivolol.

This package is child-resistant. Keep this and all drugs out of the reach of children.

Dispense in tight, light-resistant container as defined in the USP, using a child-resistant closure.

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

See package insert for dosing and full Prescribing Information.

Manufactured by:

Zhejiang Huahai Pharmaceutical Co., Ltd.

Xunqiao, Linhai, Zhejiang 317024, China

Distributed by:

Solco Healthcare US, LLC

Somerset, NJ 08873, USA

Rev.: 02/2022

10 mg 30 tablets

PRINCIPAL DISPLAY PANEL

Container Label-20 mg-30 tablets

Rx only

NDC 43547-527-03

Nebivolol Tablets

Each tablet contains: nebivolol hydrochloride equivalent to 20 mg nebivolol.

This package is child-resistant. Keep this and all drugs out of the reach of children.

Dispense in tight, light-resistant container as defined in the USP, using a child-resistant closure.

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

See package insert for dosing and full Prescribing Information.

Manufactured by:

Zhejiang Huahai Pharmaceutical Co., Ltd.

Xunqiao, Linhai, Zhejiang 317024, China

Distributed by:

Solco Healthcare US, LLC

Somerset, NJ 08873, USA

Rev.: 02/2022

20 mg 30 tablets