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FDA Drug information

ZITUVIMET XR

Read time: 1 mins
Marketing start date: 04 Apr 2025
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Summary of product characteristics


Effective Time

20240723

Version

1

Spl Product Data Elements

ZITUVIMET XR sitagliptin and metformin hydrochloride SITAGLIPTIN SITAGLIPTIN METFORMIN HYDROCHLORIDE METFORMIN ANHYDROUS DIBASIC CALCIUM PHOSPHATE CROSCARMELLOSE SODIUM FD&C YELLOW NO. 6 FERRIC OXIDE YELLOW HYPROMELLOSE 2208 (100000 MPA.S) HYPROMELLOSE 2208 (200000 MPA.S) MAGNESIUM STEARATE MALIC ACID MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE SILICON DIOXIDE SODIUM STEARYL FUMARATE STARCH, CORN TALC TITANIUM DIOXIDE Beige Colored 1805 ZITUVIMET XR sitagliptin and metformin hydrochloride SITAGLIPTIN SITAGLIPTIN METFORMIN HYDROCHLORIDE METFORMIN ANHYDROUS DIBASIC CALCIUM PHOSPHATE CROSCARMELLOSE SODIUM FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSE 2208 (100000 MPA.S) HYPROMELLOSE 2208 (200000 MPA.S) MAGNESIUM STEARATE MALIC ACID MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE SILICON DIOXIDE SODIUM STEARYL FUMARATE STARCH, CORN TALC TITANIUM DIOXIDE Light Orange to Beige Colored 1804 ZITUVIMET XR sitagliptin and metformin hydrochloride SITAGLIPTIN SITAGLIPTIN METFORMIN HYDROCHLORIDE METFORMIN ANHYDROUS DIBASIC CALCIUM PHOSPHATE CROSCARMELLOSE SODIUM FD&C YELLOW NO. 6 FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSE 2208 (100000 MPA.S) HYPROMELLOSE 2208 (200000 MPA.S) MAGNESIUM STEARATE MALIC ACID MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE SILICON DIOXIDE SODIUM STEARYL FUMARATE STARCH, CORN TALC TITANIUM DIOXIDE Reddish brown to brown colored 1806

Application Number

NDA216778

Brand Name

ZITUVIMET XR

Generic Name

sitagliptin and metformin hydrochloride

Product Ndc

70771-1879

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1879-6 ZITUVIMET XR (sitagliptin and metformin hydrochloride extended-release) tablets 50 mg/500 mg 60 Tablets Rx only NDC 70771-1880-6 ZITUVIMET XR (sitagliptin and metformin hydrochloride extended-release) tablets 50 mg/1,000 mg 60 Tablets Rx only NDC 70771-1881-3 ZITUVIMET XR (sitagliptin and metformin hydrochloride extended-release) tablets 100 mg/1,000 mg 30 Tablets Rx only 50 mg/500 mg 50 mg-1000 mg 100 mg-1000 mg

Spl Medguide

SPL MEDGUIDE

Drug section

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