Label: GLIPIZIDE AND METFORMIN HYDROCHLORIDE- glipizide and metformin hydrochloride tablet, film coated
GLIPIZIDE AND METFORMIN HYDROCHLORIDE tablet, film coated
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NDC Code(s):
65841-659-01,
65841-659-10,
65841-659-16,
65841-659-30, view more65841-659-77, 65841-660-01, 65841-660-10, 65841-660-16, 65841-660-30, 65841-660-77, 65841-661-01, 65841-661-10, 65841-661-16, 65841-661-30, 65841-661-77
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 12, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-659-01 in bottle of 100 tablets
Glipizide and Metformin Hydrochloride Tablets USP, 2.5 mg/250 mg
Rx only
100 tablets
NDC 65841-660-01 in bottle of 100 tablets
Glipizide and Metformin Hydrochloride Tablets USP, 2.5 mg/500 mg
Rx only
100 tablets
NDC 65841-661-01 in bottle of 100 tablets
Glipizide and Metformin Hydrochloride Tablets USP, 5 mg/500 mg
Rx only
100 tablets
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INGREDIENTS AND APPEARANCE
GLIPIZIDE AND METFORMIN HYDROCHLORIDE
glipizide and metformin hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-659 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C) GLIPIZIDE 2.5 mg METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE 250 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Product Characteristics Color PINK (PINK) Score no score Shape CAPSULE (CAPSULE) Size 11mm Flavor Imprint Code ZE68 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-659-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/05/2016 2 NDC:65841-659-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/05/2016 3 NDC:65841-659-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 05/05/2016 4 NDC:65841-659-77 10 in 1 CARTON 05/05/2016 4 NDC:65841-659-30 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078905 05/05/2016 GLIPIZIDE AND METFORMIN HYDROCHLORIDE
glipizide and metformin hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-660 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C) GLIPIZIDE 2.5 mg METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE 500 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Product Characteristics Color WHITE (WHITE) Score no score Shape CAPSULE (CAPSULE) Size 15mm Flavor Imprint Code ZE67 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-660-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/05/2016 2 NDC:65841-660-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/05/2016 3 NDC:65841-660-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 05/05/2016 4 NDC:65841-660-77 10 in 1 CARTON 05/05/2016 4 NDC:65841-660-30 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078905 05/05/2016 GLIPIZIDE AND METFORMIN HYDROCHLORIDE
glipizide and metformin hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-661 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C) GLIPIZIDE 5 mg METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE 500 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERRIC OXIDE RED (UNII: 1K09F3G675) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color PINK (PINK) Score no score Shape CAPSULE (CAPSULE) Size 15mm Flavor Imprint Code ZE66 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-661-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/05/2016 2 NDC:65841-661-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/05/2016 3 NDC:65841-661-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 05/05/2016 4 NDC:65841-661-77 10 in 1 CARTON 05/05/2016 4 NDC:65841-661-30 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078905 05/05/2016 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-659, 65841-660, 65841-661) , MANUFACTURE(65841-659, 65841-660, 65841-661)