NDC Code(s) : 43547-426-03, 43547-426-09, 43547-426-50, 43547-427-03, 43547-427-09, 43547-427-50, 43547-428-03, 43547-428-09, 43547-428-50
Packager : Solco Healthcare LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PIOGLITAZONEPioglitazone TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43547-426
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIOGLITAZONE(UNII: X4OV71U42S)
(PIOGLITAZONE - UNII:X4OV71U42S) 		PIOGLITAZONE15 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CARBOXYMETHYLCELLULOSE CALCIUM(UNII: UTY7PDF93L)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code 295;S
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43547-426-0330 in 1 BOTTLE Type 0: Not a Combination Product20/05/2018
2NDC:43547-426-0990 in 1 BOTTLE Type 0: Not a Combination Product20/05/2018
3NDC:43547-426-50500 in 1 BOTTLE Type 0: Not a Combination Product20/05/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207806 05/20/2018
PIOGLITAZONEPioglitazone TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43547-427
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIOGLITAZONE(UNII: X4OV71U42S)
(PIOGLITAZONE - UNII:X4OV71U42S) 		PIOGLITAZONE30 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CARBOXYMETHYLCELLULOSE CALCIUM(UNII: UTY7PDF93L)
Product Characteristics
Color WHITE (white to off white) Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code 293;S
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43547-427-0330 in 1 BOTTLE Type 0: Not a Combination Product20/05/2018
2NDC:43547-427-0990 in 1 BOTTLE Type 0: Not a Combination Product20/05/2018
3NDC:43547-427-50500 in 1 BOTTLE Type 0: Not a Combination Product20/05/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207806 05/20/2018
PIOGLITAZONEPioglitazone TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43547-428
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIOGLITAZONE(UNII: X4OV71U42S)
(PIOGLITAZONE - UNII:X4OV71U42S) 		PIOGLITAZONE45 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CARBOXYMETHYLCELLULOSE CALCIUM(UNII: UTY7PDF93L)
Product Characteristics
Color WHITE (white to off white) Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code 294;S
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43547-428-0330 in 1 BOTTLE Type 0: Not a Combination Product20/05/2018
2NDC:43547-428-0990 in 1 BOTTLE Type 0: Not a Combination Product20/05/2018
3NDC:43547-428-50500 in 1 BOTTLE Type 0: Not a Combination Product20/05/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207806 05/20/2018

LABELER - Solco Healthcare LLC(828343017)

PRINCIPAL DISPLAY PANEL

NDC 43547-426-09 Rx only

Pioglitazone Tablets, USP

15 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

90 Tablets

Each tablet contains pioglitazone hydrochloride USP, equivalent to 15 mg pioglitazone.

Do not accept if seal over bottle opening is broken or missing.

Keep this and all drugs out of the reach of children.

Usual Dosage: See package insert.

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

Dispense in a tightly closed, light-resistant container.

Protect from moisture and humidity.

Manufactured by:
Zhejiang Huahai Pharmaceutical Co., Ltd.
Xunqiao, Linhai, Zhejiang 317024, China

Distributed by:
Solco Healthcare US, LLC
Cranbury, NJ 08512, USA

17740-01
Rev.: 01/2018

Pioglitazone Tablets, 15 mg - 90 tablets

PRINCIPAL DISPLAY PANEL

NDC 43547-427-09 Rx only

Pioglitazone Tablets, USP

30 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

90 Tablets

Each tablet contains pioglitazone hydrochloride USP, equivalent to 30 mg pioglitazone.

Do not accept if seal over bottle opening is broken or missing.

Keep this and all drugs out of the reach of children.

Usual Dosage: See package insert.

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

Dispense in a tightly closed, light-resistant container.

Protect from moisture and humidity.

Manufactured by:
Zhejiang Huahai Pharmaceutical Co., Ltd.
Xunqiao, Linhai, Zhejiang 317024, China

Distributed by:
Solco Healthcare US, LLC
Cranbury, NJ 08512, USA

17743-01
Rev.: 01/2018

Pioglitazone Tablets, 30 mg - 90 tablets

PRINCIPAL DISPLAY PANEL

NDC 43547-428-09 Rx only

Pioglitazone Tablets, USP

45 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

90 Tablets

Each tablet contains pioglitazone hydrochloride USP, equivalent to 45 mg pioglitazone.

Do not accept if seal over bottle opening is broken or missing.

Keep this and all drugs out of the reach of children.

Usual Dosage: See package insert.

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

Dispense in a tightly closed, light-resistant container.

Protect from moisture and humidity.

Manufactured by:
Zhejiang Huahai Pharmaceutical Co., Ltd.
Xunqiao, Linhai, Zhejiang 317024, China

Distributed by:
Solco Healthcare US, LLC
Cranbury, NJ 08512, USA

17746-01
Rev.: 01/2018

Pioglitazone Tablets, 45 mg - 90 tablets