Label: 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
Sitagliptin and metformin hydrochloride extended-release tablets for oral use
50 mg/500 mg
60 Tablets
Rx only
Sitagliptin and metformin hydrochloride extended-release tablets for oral use
50 mg/1000 mg
60 Tablets
Rx only
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
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
sitagliptin and metformin hydrochloride tablet, film coated, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1886 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:70771-1886-6 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 authorized generic NDA216778 10/31/2024 SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
sitagliptin and metformin hydrochloride tablet, film coated, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1887 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:70771-1887-6 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 authorized generic NDA216778 10/31/2024 SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
sitagliptin and metformin hydrochloride tablet, film coated, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1888 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:70771-1888-3 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 authorized generic NDA216778 10/31/2024 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Global FZE (850107010) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1886, 70771-1887, 70771-1888) , MANUFACTURE(70771-1886, 70771-1887, 70771-1888)