AMLODIPINE BESYLATE

Manufacturer
Vivimed Labs Limited | Strides Vivimed Pte. Ltd. | Vivimed Life Sciences Private Limited
Effective date
2018-12-13
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:39:15

Label at a glance#

ProductAMLODIPINE BESYLATE 2.5 mg
Active ingredientAMLODIPINE BESYLATE
Label structure2 sections

Storage and handling

2.5 mg Tablets Amlodipine Besylate Tablets USP, 2.5 mg (amlodipine besylate USP equivalent to 2.5 mg of amlodipine per tablet) are supplied as white, round, flat face beveled edge tablets debossed on  one side and “20” on the other side and supplied as follows NDC 62980-506-01       Bottle of 90 tablets NDC 62980-506-02       Bottle of 300 tablets NDC 62980-506-03       Bottle of 500 tablets NDC 62980-506-04      ...

Label contents#

Full prescribing information#

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

2.5 mg Tablets
Amlodipine Besylate Tablets USP, 2.5 mg (amlodipine besylate USP equivalent to 2.5 mg of amlodipine per tablet) are supplied as white, round, flat face beveled edge tablets debossed on image01image01 one side and “20” on the other side and supplied as follows
NDC 62980-506-01       Bottle of 90 tablets
NDC 62980-506-02       Bottle of 300 tablets
NDC 62980-506-03       Bottle of 500 tablets
NDC 62980-506-04       Bottle of 1000 tablets

5 mg Tablets
Amlodipine Besylate Tablets USP, 5 mg (amlodipine besylate USP equivalent to 5 mg of amlodipine per tablet) are supplied as white, round, flat face beveled edge tablets debossed on image02image02 one side and “21” on the other side and supplied as follows:
NDC 62980-507-01       Bottle of 90 tablets
NDC 62980-507-02       Bottle of 300 tablets
NDC 62980-507-03       Bottle of 500 tablets
NDC 62980-507-04       Bottle of 1000 tablets

10 mg Tablets
Amlodipine Besylate Tablets USP, 10 mg (amlodipine besylate USP equivalent to 10 mg of amlodipine per tablet) are supplied as white, round, flat face beveled edge tablets debossed image03image0322” on one side and plain on the other side and supplied as follows:
NDC 62980-508-01      Bottle of 90 tablets
NDC 62980-508-02      Bottle of 300 tablets
NDC 62980-508-03      Bottle of 500 tablets
NDC 62980-508-04      Bottle of 1000 tablets

Storage

SPL UNCLASSIFIED SECTION

Store bottles at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). [See USP Controlled Room Temperature]. Dispense in tight, light-resistant containers (USP).

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62980-506-01
Amlodipine Besylate Tablets USP
2.5 mg
PHARMACIST: Dispense with Patient Information Leaflet.
Rx only
90 Tablets

Vivimed

image04image04

NDC 62980-507-01

Amlodipine Besylate Tablets USP
5 mg
PHARMACIST: Dispense with Patient Information Leaflet.
Rx only
90 Tablets

Vivimed

image05image05

NDC 62980-508-01

Amlodipine Besylate Tablets USP
10 mg
PHARMACIST: Dispense with Patient Information Leaflet.
Rx only
90 Tablets

Vivimed

image06image06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077516-001AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2007-07-11
A077516-002AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2007-07-11
A077516-003AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2007-07-11

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A077516-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2007-07-11c2088c7a36db…
2026-10-15 13:18:302026-09A077516-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2007-07-11c2088c7a36db…
2026-10-15 13:18:302026-09A077516-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2007-07-11c2088c7a36db…
2026-09-14 22:38:342026-08A077516-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2007-07-1184e616aacf4f…
2026-09-14 22:38:342026-08A077516-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2007-07-1184e616aacf4f…
2026-09-14 22:38:342026-08A077516-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2007-07-1184e616aacf4f…
2026-08-18 06:07:402026-07A077516-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2007-07-11caaa826d4ba7…
2026-08-18 06:07:402026-07A077516-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2007-07-11caaa826d4ba7…
2026-08-18 06:07:402026-07A077516-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2007-07-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077516-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077516-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077516-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077516-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077516-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077516-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077516-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077516-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077516-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077516-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077516-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077516-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077516-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077516-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077516-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077516-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077516-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077516-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077516-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077516-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077516-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077516-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077516-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077516-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077516-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077516-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077516-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077516-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A077516-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A077516-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077516-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-1179d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077516-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077516-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077516-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077516-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077516-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077516-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077516-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077516-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077516-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077516-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077516-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077516-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077516-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077516-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077516-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077516-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077516-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077516-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077516-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077516-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077516-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077516-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077516-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077516-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077516-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077516-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077516-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077516-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077516-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077516-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077516-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077516-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077516-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077516-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077516-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077516-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077516-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077516-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077516-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077516-001AB18072bd15b7f6…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1b9dc9c3-2317-4297-a46a-76c2ce604ccb4b0616ab-8d0a-4310-b6b1-5d22c32a4da52019-11-26Exact identifier
spl set id: 4b0616ab-8d0a-4310-b6b1-5d22c32a4da5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.