Pill Identifier Information of metformin hydrochloride 500 MG 24 HR Extended Release Tablet
Drug Information
metformin hydrochloride 500 MG 24 HR Extended Release Tablet
| Imprint: | 63;Z |
| Shape: | C48336 |
| Color: | C48325 |
| Ingredients: | Metformin |
| Size: | 19.00 |
| Score: | 1 |
| Rxtty: | SY |
| Author: | Cadila Healthcare Limited |
| Inactive Ingredients: | GLYCERYL BEHENATE / HYPROMELLOSES / POVIDONE / CELLULOSE, MICROCRYSTALLINE> |
Complete Information
- SPL UNCLASSIFIED SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-809-01 in bottle of 100 tablets
Metformin Hydrochloride Tablets USP, 500 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 65841-811-01 in bottle of 100 tablets
Metformin Hydrochloride Tablets USP, 1000 mg
Rx only
100 tablets
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INGREDIENTS AND APPEARANCE
METFORMIN HYDROCHLORIDEÂ
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 HYDROCHLORIDEÂ
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 HYDROCHLORIDEÂ
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(65841-809, 65841-810, 65841-811) , MANUFACTURE(65841-809, 65841-810, 65841-811) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(65841-809, 65841-810, 65841-811) , MANUFACTURE(65841-809, 65841-810, 65841-811)