Amlodipine Besylate

Product NDC
0054-0101
11-digit product format
000540101
Labeler code
0054
Product ID
0054-0101_236a1b97-e056-4b91-b263-c53e95275adf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
West-Ward Pharmaceuticals Corp.
Application
ANDA077262
Marketing category
ANDA
Marketing start
2007-07-09
Marketing end
2020-08-20
Substance
AMLODIPINE BESYLATE
Active strength
5 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0054-0101DDiscontinued by firm2026-08-17
excluded packagepackage0054-01010054-0101-20DDiscontinued by firm2026-08-17
excluded packagepackage0054-01010054-0101-22DDiscontinued by firm2026-08-17
excluded packagepackage0054-01010054-0101-28DDiscontinued by firm2026-08-17
excluded packagepackage0054-01010054-0101-31DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 60 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0054-0101-22d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0054-0101-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0054-0101-31d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0054-0101-28d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0054-0101-22f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0054-0101-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0054-0101-31f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0054-0101-28f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0054-0101-222ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0054-0101-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0054-0101-312ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0054-0101-282ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0054-0101-22a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0054-0101-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0054-0101-31a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0054-0101-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0054-0101-22cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0054-0101-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0054-0101-31cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0054-0101-28cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0054-0101-22cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0054-0101-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0054-0101-31cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0054-0101-28cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0054-0101-22302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0054-0101-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0054-0101-31302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0054-0101-28302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0054-0101-22ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0054-0101-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0054-0101-31ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0054-0101-28ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0054-0101-220efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0054-0101-200efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0054-0101-310efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0054-0101-280efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0054-0101-22ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0054-0101-20ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0054-0101-31ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0054-0101-28ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0054-0101-22367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0054-0101-20367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0054-0101-31367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0054-0101-28367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0054-0101-22557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0054-0101-20557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0054-0101-31557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0054-0101-28557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A077262-001AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2007-07-09
A077262-002AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2007-07-09
A077262-003AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2007-07-09

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077262-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2007-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07A077262-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2007-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07A077262-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2007-07-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077262-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2007-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077262-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2007-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077262-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2007-07-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077262-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2007-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077262-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2007-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077262-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2007-07-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A077262-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2007-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077262-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2007-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077262-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2007-07-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077262-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2007-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077262-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2007-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077262-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2007-07-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077262-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2007-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077262-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2007-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077262-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2007-07-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077262-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2007-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077262-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2007-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077262-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2007-07-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077262-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2007-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077262-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2007-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077262-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2007-07-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077262-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2007-07-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077262-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2007-07-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077262-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2007-07-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077262-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2007-07-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077262-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2007-07-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077262-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2007-07-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077262-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2007-07-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A077262-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2007-07-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A077262-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2007-07-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077262-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2007-07-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077262-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2007-07-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077262-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2007-07-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077262-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2007-07-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077262-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2007-07-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077262-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2007-07-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077262-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2007-07-091e350fbaab3a…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A077262-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077262-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077262-003AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A077262-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077262-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077262-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077262-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077262-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077262-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077262-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077262-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077262-003AB1ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0101-22EA - Each0054-01012b6e7627-d46b-4f8c-8052-48d1252a863d12012-07-24
0054-0101-28EA - Each0054-01017ba79814-92c8-41a2-8717-0f5ba92c344d12012-07-24
0054-0101-31EA - Each0054-0101d4403c2e-6e83-4077-8102-0019edd4ac8712015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [ROXANE LABORATORIES, INC]9
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [ROXANE LABORATORIES, INC]9
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPAMLODIPINE BESYLATE TABLET [ROXANE LABORATORIES, INC]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [ROXANE LABORATORIES, INC]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [ROXANE LABORATORIES, INC]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [ROXANE LABORATORIES, INC]9