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FDA Product

Glipizide and Metformin HCl

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Glipizide and Metformin HCl

71205-270

Regulatory Information

71205-270

ANDA078728

C73584

May 1, 2019

USA

Glipizide and Metformin HCl Tablets USP These highlights do not include all the information needed to use Glipizide and Metformin HCl safely and effectively. See full prescribing information for Glipizide and Metformin HCl Glipizide and Metformin HCl (Glipizide and Metformin HCl) TABLET, FILM COATED for ORAL use. Initial U.S. Approval:

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

Proficient Rx LP

079196022

Active Ingredients

GLIPIZIDE

Quantity: 5 mg in 1 1

Code: X7WDT95N5C

Class Code: ACTIB

METFORMIN HYDROCHLORIDE

Quantity: 500 mg in 1 1

Code: 786Z46389E

Class Code: ACTIB

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

POLYETHYLENE GLYCOL 6000

Code: 30IQX730WE

Class Code: IACT

HYPROMELLOSE 2910 (15 MPA.S)

Code: 36SFW2JZ0W

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

Active Moieties

GLIPIZIDE

Code: X7WDT95N5C

METFORMIN

Code: 9100L32L2N

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