ZITUVIMET XR- sitagliptin and metformin hydrochloride tablet, film coated, extended release

ZITUVIMET XR by

Drug Labeling and Warnings

ZITUVIMET XR by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

SPL MEDGUIDE

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

INGREDIENTS AND APPEARANCE

ZITUVIMET XR 
sitagliptin and metformin hydrochloride tablet, film coated, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1880
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SITAGLIPTIN (UNII: QFP0P1DV7Z) (SITAGLIPTIN - UNII:QFP0P1DV7Z)	SITAGLIPTIN	50 mg
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)	METFORMIN HYDROCHLORIDE	1000 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)
HYPROMELLOSE 2208 (200000 MPA.S) (UNII: LJY3MA129D)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALIC ACID (UNII: 817L1N4CKP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	YELLOW (Beige Colored)	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	1805
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1880-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	10/31/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA216778	10/31/2024

ZITUVIMET XR 
sitagliptin and metformin hydrochloride tablet, film coated, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1879
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SITAGLIPTIN (UNII: QFP0P1DV7Z) (SITAGLIPTIN - UNII:QFP0P1DV7Z)	SITAGLIPTIN	50 mg
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)	METFORMIN HYDROCHLORIDE	500 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)
HYPROMELLOSE 2208 (200000 MPA.S) (UNII: LJY3MA129D)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALIC ACID (UNII: 817L1N4CKP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE (Light Orange to Beige Colored)	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	1804
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1879-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	10/31/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA216778	10/31/2024

ZITUVIMET XR 
sitagliptin and metformin hydrochloride tablet, film coated, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1881
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SITAGLIPTIN (UNII: QFP0P1DV7Z) (SITAGLIPTIN - UNII:QFP0P1DV7Z)	SITAGLIPTIN	100 mg
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)	METFORMIN HYDROCHLORIDE	1000 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)
HYPROMELLOSE 2208 (200000 MPA.S) (UNII: LJY3MA129D)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALIC ACID (UNII: 817L1N4CKP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BROWN (Reddish brown to brown colored)	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	1806
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1881-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	10/31/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA216778	10/31/2024

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1879, 70771-1880, 70771-1881) , MANUFACTURE(70771-1879, 70771-1880, 70771-1881)