Label: METFORMIN HYDROCHLORIDE tablet, film coated
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NDC Code(s):
65841-028-01,
65841-028-05,
65841-028-10,
65841-028-16, view more65841-028-30, 65841-028-77, 65841-029-01, 65841-029-05, 65841-029-10, 65841-029-16, 65841-029-30, 65841-029-77, 65841-030-01, 65841-030-05, 65841-030-10, 65841-030-16, 65841-030-30, 65841-030-77, 65841-809-01, 65841-809-05, 65841-809-10, 65841-809-16, 65841-809-30, 65841-809-77, 65841-810-01, 65841-810-05, 65841-810-10, 65841-810-16, 65841-810-30, 65841-810-77, 65841-811-01, 65841-811-05, 65841-811-10, 65841-811-16, 65841-811-30, 65841-811-77
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 31, 2022
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-028-01 in bottle of 100 tablets
Metformin Hydrochloride Tablets USP, 500 mg
Rx only
100 tablets
NDC 65841-809-01 in bottle of 100 tablets
Metformin Hydrochloride Tablets USP, 500 mg
Rx only
100 tablets
NDC 65841-029-01 in bottle of 100 tablets
Metformin Hydrochloride Tablets USP, 850 mg
Rx only
100 tablets
NDC 65841-810-01 in bottle of 100 tablets
Metformin Hydrochloride Tablets USP, 850 mg
Rx only
100 tablets
NDC 65841-030-01 in bottle of 100 tablets
Metformin Hydrochloride Tablets USP, 1000 mg
Rx only
100 tablets
NDC 65841-811-01 in bottle of 100 tablets
Metformin Hydrochloride Tablets USP, 1000 mg
Rx only
100 tablets
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INGREDIENTS AND APPEARANCE
METFORMIN HYDROCHLORIDE
metformin hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-028 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE 500 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 13mm Flavor Imprint Code 70;Z Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-028-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 09/28/2005 2 NDC:65841-028-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/28/2005 3 NDC:65841-028-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/28/2005 4 NDC:65841-028-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 09/28/2005 5 NDC:65841-028-77 100 in 1 CARTON 09/28/2005 5 NDC:65841-028-30 1 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 ANDA077064 09/28/2005 METFORMIN HYDROCHLORIDE
metformin hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-029 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE 850 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape OVAL (OVAL) Size 19mm Flavor Imprint Code 69;Z Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-029-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 09/28/2005 2 NDC:65841-029-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/28/2005 3 NDC:65841-029-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/28/2005 4 NDC:65841-029-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 09/28/2005 5 NDC:65841-029-77 100 in 1 CARTON 09/28/2005 5 NDC:65841-029-30 1 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 ANDA077064 09/28/2005 METFORMIN HYDROCHLORIDE
metformin hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-030 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE 1000 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score 2 pieces Shape OVAL (OVAL) Size 19mm Flavor Imprint Code Z;71 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-030-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 09/28/2005 2 NDC:65841-030-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/28/2005 3 NDC:65841-030-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/28/2005 4 NDC:65841-030-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 09/28/2005 5 NDC:65841-030-77 100 in 1 CARTON 09/28/2005 5 NDC:65841-030-30 1 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 ANDA077064 09/28/2005 METFORMIN HYDROCHLORIDE
metformin hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-809 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE 500 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 13mm Flavor Imprint Code 70;Z Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-809-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/09/2014 2 NDC:65841-809-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/09/2014 3 NDC:65841-809-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/09/2014 4 NDC:65841-809-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/09/2014 5 NDC:65841-809-77 100 in 1 CARTON 12/09/2014 5 NDC:65841-809-30 1 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 ANDA203686 12/09/2014 METFORMIN HYDROCHLORIDE
metformin hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-810 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE 850 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape OVAL (OVAL) Size 19mm Flavor Imprint Code 69;Z Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-810-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/09/2014 2 NDC:65841-810-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/09/2014 3 NDC:65841-810-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/09/2014 4 NDC:65841-810-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/09/2014 5 NDC:65841-810-77 100 in 1 CARTON 12/09/2014 5 NDC:65841-810-30 1 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 ANDA203686 12/09/2014 METFORMIN HYDROCHLORIDE
metformin hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-811 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE 1000 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score 2 pieces Shape OVAL (OVAL) Size 19mm Flavor Imprint Code Z;71 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-811-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/09/2014 2 NDC:65841-811-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/09/2014 3 NDC:65841-811-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/09/2014 4 NDC:65841-811-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/09/2014 5 NDC:65841-811-77 100 in 1 CARTON 12/09/2014 5 NDC:65841-811-30 1 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 ANDA203686 12/09/2014 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-028, 65841-029, 65841-030, 65841-809, 65841-810, 65841-811) , MANUFACTURE(65841-028, 65841-029, 65841-030, 65841-809, 65841-810, 65841-811) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(65841-028, 65841-029, 65841-030, 65841-809, 65841-810, 65841-811) , MANUFACTURE(65841-028, 65841-029, 65841-030, 65841-809, 65841-810, 65841-811)