NDC Code(s) : 43547-503-10, 43547-503-50, 43547-504-09, 43547-504-50
Packager : Solco Healthcare US, LLC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

METFORMIN HYDROCHLORIDEmetformin hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43547-503
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E)
(METFORMIN - UNII:9100L32L2N) 		METFORMIN HYDROCHLORIDE500 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA(UNII: 5138Q19F1X)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
CROSPOVIDONE(UNII: 2S7830E561)
SHELLAC(UNII: 46N107B71O)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
VINYL ACETATE(UNII: L9MK238N77)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL Size 16 mm
Flavor Imprint Code 618
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43547-503-10100 in 1 BOTTLE Type 0: Not a Combination Product31/05/2022
2NDC:43547-503-50500 in 1 BOTTLE Type 0: Not a Combination Product31/05/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212681 05/31/2022
METFORMIN HYDROCHLORIDEmetformin hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43547-504
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E)
(METFORMIN - UNII:9100L32L2N) 		METFORMIN HYDROCHLORIDE1000 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA(UNII: 5138Q19F1X)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
CROSPOVIDONE(UNII: 2S7830E561)
SHELLAC(UNII: 46N107B71O)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
VINYL ACETATE(UNII: L9MK238N77)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL Size 20 mm
Flavor Imprint Code 619
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43547-504-0990 in 1 BOTTLE Type 0: Not a Combination Product31/05/2022
2NDC:43547-504-50500 in 1 BOTTLE Type 0: Not a Combination Product31/05/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212681 05/31/2022

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(43547-503, 43547-504)

PRINCIPAL DISPLAY PANEL

Container Label-500 mg-100 tablets

Rx only

NDC 43547-503-10

Metformin Hydrochloride Extended-Release Tablets, USP

Each extended-release tablet contains:

500 mg metformin hydrochloride, USP.

Usual Dosage: See package insert for prescribing information.

WARNING: Keep out of reach of children.

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

Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

Manufactured by:

Zhejiang Huahai Pharmaceutical Co., Ltd.

Xunqiao, Linhai, Zhejiang 317024, China

Distributed by:

Solco Healthcare US, LLC

Somerset, NJ 08873, USA

Product of China.

Rev.: 05/2022

500 mg 100 Tablets

PRINCIPAL DISPLAY PANEL

Container Label-1,000 mg-90 tablets

Rx only

NDC 43547-504-09

Metformin Hydrochloride Extended-Release Tablets, USP

Each extended-release tablet contains:

1,000 mg metformin hydrochloride, USP.

Usual Dosage: See package insert for prescribing information.

WARNING: Keep out of reach of children.

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

Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

Manufactured by:

Zhejiang Huahai Pharmaceutical Co., Ltd.

Xunqiao, Linhai, Zhejiang 317024, China

Distributed by:

Solco Healthcare US, LLC

Somerset, NJ 08873, USA

Product of China.

Rev.: 05/2022

1000mg 90 Tablets