DailyMed - SITAGLIPTIN AND METFORMIN HYDROCHLORIDE tablet, film coated, extended release

NDC Code(s): 70771-1886-6, 70771-1887-6, 70771-1888-3
Packager: Zydus Lifesciences Limited

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

Drug Label Information

Updated August 24, 2024

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1886-6 - Sitagliptin and metformin hydrochloride extended-release tablets for oral use - 50 mg/500 mg - 60 Tablets - Rx only - NDC 70771-1887-6 - Sitagliptin and metformin hydrochloride ...

NDC 70771-1886-6

Sitagliptin and metformin hydrochloride extended-release tablets for oral use

50 mg/500 mg

60 Tablets

Rx only

NDC 70771-1887-6

Sitagliptin and metformin hydrochloride extended-release tablets for oral use

50 mg/1000 mg

60 Tablets

Rx only

NDC 70771-1888-3

Sitagliptin and metformin hydrochloride extended-release tablets for oral use

100 mg/1000 mg

30 Tablets

Rx only

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INGREDIENTS AND APPEARANCE

Product Information

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE sitagliptin and metformin hydrochloride tablet, film coated, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1886
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:70771-1886-6	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 authorized generic	NDA216778	10/31/2024

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE sitagliptin and metformin hydrochloride tablet, film coated, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1887
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:70771-1887-6	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 authorized generic	NDA216778	10/31/2024

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE sitagliptin and metformin hydrochloride tablet, film coated, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1888
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:70771-1888-3	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 authorized generic	NDA216778	10/31/2024

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Global FZE (850107010)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1886, 70771-1887, 70771-1888) , MANUFACTURE(70771-1886, 70771-1887, 70771-1888)

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	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

Label: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE tablet, film coated, extended release

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	NDC
1	70771-1886-6
2	70771-1887-6
3	70771-1888-3

Label: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE tablet, film coated, extended release

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SITAGLIPTIN AND METFORMIN HYDROCHLORIDE tablet, film coated, extended release

Number of versions: 1

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE tablet, film coated, extended release

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE tablet, film coated, extended release

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SITAGLIPTIN AND METFORMIN HYDROCHLORIDE tablet, film coated, extended release

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.