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

NDC Code(s): 70771-1879-6, 70771-1880-6, 70771-1881-3
Packager: Zydus Lifesciences Limited

Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: None
Marketing Status: New Drug Application

Drug Label Information

Updated July 23, 2024

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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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Labeler - Zydus Lifesciences Limited (918596198)

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

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Published Date (What is this?)	Version	Files
Nov 1, 2024	1 (current)	download

	RxCUI	RxNorm NAME	RxTTY
1	1243827	SITagliptin 100 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet	PSN
2	1243827	24 HR metformin hydrochloride 1000 MG / sitagliptin 100 MG Extended Release Oral Tablet	SCD
3	1243827	metformin hydrochloride 1000 MG / sitagliptin (as sitagliptin phosphate monohydrate) 100 MG 24 HR Extended Release Oral Tablet	SY
4	1243842	SITagliptin 50 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet	PSN
5	1243842	24 HR metformin hydrochloride 1000 MG / sitagliptin 50 MG Extended Release Oral Tablet	SCD
6	1243842	metformin hydrochloride 1000 MG / sitagliptin (as sitagliptin phosphate monohydrate) 50 MG 24 HR Extended Release Oral Tablet	SY
7	1243846	SITagliptin 50 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN
8	1243846	24 HR metformin hydrochloride 500 MG / sitagliptin 50 MG Extended Release Oral Tablet	SCD
9	1243846	metformin hydrochloride 500 MG / sitagliptin (as sitagliptin phosphate) 50 MG 24 HR Extended Release Oral Tablet	SY
10	2696282	Zituvimet XR 50 MG / 1000 MG 24HR Extended Release Oral Tablet	PSN
11	2696282	24 HR metformin hydrochloride 1000 MG / sitagliptin 50 MG Extended Release Oral Tablet [Zituvimet]	SBD
12	2696282	Zituvimet XR 50/1000 24 HR Extended Release Oral Tablet	SY
13	2696284	Zituvimet XR 50 MG / 500 MG 24HR Extended Release Oral Tablet	PSN
14	2696284	24 HR metformin hydrochloride 500 MG / sitagliptin 50 MG Extended Release Oral Tablet [Zituvimet]	SBD
15	2696284	Zituvimet XR 50/500 24 HR Extended Release Oral Tablet	SY
16	2696287	Zituvimet XR 100 MG / 1000 MG 24HR Extended Release Oral Tablet	PSN
17	2696287	24 HR metformin hydrochloride 1000 MG / sitagliptin 100 MG Extended Release Oral Tablet [Zituvimet]	SBD
18	2696287	Zituvimet XR 100/1000 24 HR Extended Release Oral Tablet	SY

RxCUI

RxNorm NAME

RxTTY

1243827

SITagliptin 100 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet

PSN

1243827

24 HR metformin hydrochloride 1000 MG / sitagliptin 100 MG Extended Release Oral Tablet

SCD

1243827

metformin hydrochloride 1000 MG / sitagliptin (as sitagliptin phosphate monohydrate) 100 MG 24 HR Extended Release Oral Tablet

1243842

SITagliptin 50 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet

PSN

1243842

24 HR metformin hydrochloride 1000 MG / sitagliptin 50 MG Extended Release Oral Tablet

SCD

1243842

metformin hydrochloride 1000 MG / sitagliptin (as sitagliptin phosphate monohydrate) 50 MG 24 HR Extended Release Oral Tablet

1243846

SITagliptin 50 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet

PSN

1243846

24 HR metformin hydrochloride 500 MG / sitagliptin 50 MG Extended Release Oral Tablet

SCD

1243846

metformin hydrochloride 500 MG / sitagliptin (as sitagliptin phosphate) 50 MG 24 HR Extended Release Oral Tablet

2696282

Zituvimet XR 50 MG / 1000 MG 24HR Extended Release Oral Tablet

PSN

2696282

24 HR metformin hydrochloride 1000 MG / sitagliptin 50 MG Extended Release Oral Tablet [Zituvimet]

SBD

2696282

Zituvimet XR 50/1000 24 HR Extended Release Oral Tablet

2696284

Zituvimet XR 50 MG / 500 MG 24HR Extended Release Oral Tablet

PSN

2696284

24 HR metformin hydrochloride 500 MG / sitagliptin 50 MG Extended Release Oral Tablet [Zituvimet]

SBD

2696284

Zituvimet XR 50/500 24 HR Extended Release Oral Tablet

2696287

Zituvimet XR 100 MG / 1000 MG 24HR Extended Release Oral Tablet

PSN

2696287

24 HR metformin hydrochloride 1000 MG / sitagliptin 100 MG Extended Release Oral Tablet [Zituvimet]

SBD

2696287

Zituvimet XR 100/1000 24 HR Extended Release Oral Tablet

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

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	NDC
1	70771-1879-6
2	70771-1880-6
3	70771-1881-3

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

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

Number of versions: 1

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

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

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

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