Amlodipine Besylate

Product NDC
53808-0653
11-digit product format
538080653
Labeler code
53808
Product ID
53808-0653_24efe210-73f3-446c-a8d3-88baa1508702
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine besylate
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA076418
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE
Active strength
3 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53808-0653IInactivated by FDA2026-08-17
excluded packagepackage53808-065353808-0653-1IInactivated by FDA2026-08-17

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 · 44 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 packagepackage53808-0653-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53808-0653-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53808-0653-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53808-0653-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53808-0653-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53808-0653-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53808-0653-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53808-0653-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53808-0653-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53808-0653-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53808-0653-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53808-0653-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53808-0653-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53808-0653-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53808-0653-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53808-0653-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53808-0653-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53808-0653-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53808-0653-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53808-0653-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53808-0653-19bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage53808-0653-1110d247fa046…a55b01930146…

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
A076418-001AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-03
A076418-002AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-03
A076418-003AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-03

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 06:07:402026-07A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-03caaa826d4ba7…
2026-08-18 06:07:402026-07A076418-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-03caaa826d4ba7…
2026-08-18 06:07:402026-07A076418-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076418-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076418-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076418-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076418-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076418-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076418-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076418-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076418-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076418-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076418-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076418-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076418-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076418-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076418-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076418-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076418-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076418-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076418-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A076418-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A076418-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076418-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076418-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076418-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076418-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-031e350fbaab3a…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A076418-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076418-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076418-003AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A076418-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076418-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076418-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076418-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076418-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076418-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076418-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076418-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076418-003AB1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
265792b3-b999-c010-7364-a7db20b9d4d9Product name520250515
14c2c15b-f823-4ada-a40e-a440544294dcProduct name120221207
a72887ef-d675-499f-af4b-78688f6855cdProduct name120191002
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211
18600d07-613d-bf9c-2711-fe40c06f3393Product name520180703
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product name120150316
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0653-12021-01-29C16284748780-1956f9ecf-df02-621f-e053-dbdaa90a74ada10fa641-ac6b-466d-bcba-31c678a74be8
53808-0653-12019-10-21C16284748780-1956f9ecf-df02-621f-e053-dbdaa90a74ada10fa641-ac6b-466d-bcba-31c678a74be8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0653-1Amlodipine Besylate30 in 1 BLISTER PACKTABLET304

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]4
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]4
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0653AMLODIPINE BESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]4Legacy NDC, 1 package rows20100824_a10fa641-ac6b-466d-bcba-31c678a74be8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308136amLODIPine besylate 2.5 MG Oral TabletPSNa10fa641-ac6b-466d-bcba-31c678a74be84
197361amLODIPine besylate 5 MG Oral TabletPSNa10fa641-ac6b-466d-bcba-31c678a74be84
308136amlodipine 2.5 MG Oral TabletSCDa10fa641-ac6b-466d-bcba-31c678a74be84
197361amlodipine 5 MG Oral TabletSCDa10fa641-ac6b-466d-bcba-31c678a74be84
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSYa10fa641-ac6b-466d-bcba-31c678a74be84
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYa10fa641-ac6b-466d-bcba-31c678a74be84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0653-15380806530130 in 1 BLISTER PACKHistorical