Label: AMLODIPINE BESYLATE tablet
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NDC Code(s):
65841-620-01,
65841-620-05,
65841-620-16,
65841-620-77, view more65841-621-01, 65841-621-05, 65841-621-16, 65841-621-77, 65841-622-01, 65841-622-05, 65841-622-16, 65841-622-77
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated September 18, 2023
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INGREDIENTS AND APPEARANCE
AMLODIPINE BESYLATE
amlodipine besylate tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-620 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE 2.5 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 4mm Flavor Imprint Code Z;7 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-620-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 09/21/2007 2 NDC:65841-620-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/21/2007 3 NDC:65841-620-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/21/2007 4 NDC:65841-620-77 10 in 1 CARTON 09/21/2007 4 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 ANDA078226 09/21/2007 AMLODIPINE BESYLATE
amlodipine besylate tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-621 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE 5 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code Z;3 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-621-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 09/21/2007 2 NDC:65841-621-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/21/2007 3 NDC:65841-621-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/21/2007 4 NDC:65841-621-77 10 in 1 CARTON 09/21/2007 4 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 ANDA078226 09/21/2007 AMLODIPINE BESYLATE
amlodipine besylate tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-622 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE 10 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 8mm Flavor Imprint Code Z;5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-622-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 09/21/2007 2 NDC:65841-622-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/21/2007 3 NDC:65841-622-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/21/2007 4 NDC:65841-622-77 10 in 1 CARTON 09/21/2007 4 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 ANDA078226 09/21/2007 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 677605858 ANALYSIS(65841-620, 65841-621, 65841-622) , MANUFACTURE(65841-620, 65841-621, 65841-622) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-620, 65841-621, 65841-622) , MANUFACTURE(65841-620, 65841-621, 65841-622)
