Amlodipine Besylate Tablets

SPL v13

SPL

SPL Set ID cacb3551-c579-41cb-bed6-4b4d8b0644fc

Route

ORAL

Published

Effective Date 2023-09-18

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Amlodipine (2.5 mg)

Inactive Ingredients

Magnesium Stearate Sodium Starch Glycolate Type A Potato Silicon Dioxide Cellulose, Microcrystalline

Identifiers & Packaging

Pill Appearance

Imprint: Z;5 Shape: round Color: white Size: 4 mm Size: 6 mm Size: 8 mm Score: 1

Marketing Status

ANDA Active Since 2007-09-21

Description

NDC 65841-620-16 in bottle of 90 tablets Amlodipine Besylate Tablets USP, 2.5 mg Rx only 90 tablets NDC 65841-621-16 in bottle of 90 tablets Amlodipine Besylate Tablets USP, 5 mg Rx only 90 tablets NDC 65841-622-16 in bottle of 90 tablets Amlodipine Besylate Tablets USP, 10 mg Rx only 90 tablets

Medication Information

Description

Package Label.principal Display Panel

NDC 65841-620-16 in bottle of 90 tablets

Amlodipine Besylate Tablets USP, 2.5 mg

Rx only

90 tablets

NDC 65841-621-16 in bottle of 90 tablets

Amlodipine Besylate Tablets USP, 5 mg

Rx only

90 tablets

NDC 65841-622-16 in bottle of 90 tablets

Amlodipine Besylate Tablets USP, 10 mg

Rx only

90 tablets

Structured Label Content

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 65841-620-16 in bottle of 90 tablets

Amlodipine Besylate Tablets USP, 2.5 mg

Rx only

90 tablets

NDC 65841-621-16 in bottle of 90 tablets

Amlodipine Besylate Tablets USP, 5 mg

Rx only

90 tablets

NDC 65841-622-16 in bottle of 90 tablets

Amlodipine Besylate Tablets USP, 10 mg

Rx only

90 tablets

Advanced Ingredient Data

[{"name": "AMLODIPINE", "unii": "1J444QC288", "classCode": "ACTIM", "strengthNumerator": "2.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMLODIPINE", "unii": "1J444QC288", "classCode": "ACTIM", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMLODIPINE", "unii": "1J444QC288", "classCode": "ACTIM", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 65841-620-16 in bottle of 90 tablets Amlodipine Besylate Tablets USP, 2.5 mg Rx only 90 tablets NDC 65841-621-16 in bottle of 90 tablets Amlodipine Besylate Tablets USP, 5 mg Rx only 90 tablets NDC 65841-622-16 in bottle of 90 tablets Amlodipine Besylate Tablets USP, 10 mg Rx only 90 tablets"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:43:57.504839 · Updated: 2026-03-14T22:18:11.806691