Amlodipine Besylate

Product NDC
33261-826
11-digit product format
332610826
Labeler code
33261
Product ID
33261-826_0d247451-52f8-45ba-a1ec-91401605c8d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA077995
Marketing category
ANDA
Marketing start
2011-01-01
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
2018-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct33261-826IInactivated by FDA2026-10-12
excluded packagepackage33261-82633261-826-30IInactivated by FDA2026-10-12
excluded packagepackage33261-82633261-826-60IInactivated by FDA2026-10-12
excluded packagepackage33261-82633261-826-90IInactivated by FDA2026-10-12

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 2 · 88 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 packagepackage33261-826-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-826-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-826-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-826-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-826-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-826-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-826-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-826-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-826-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-826-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-826-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-826-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-826-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-826-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-826-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-826-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-826-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-826-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-826-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-826-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-826-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-826-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-826-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-826-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-826-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-826-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-826-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33261-826-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33261-826-90ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33261-826-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage33261-826-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage33261-826-90367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage33261-826-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage33261-826-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage33261-826-90557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage33261-826-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage33261-826-608af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage33261-826-908af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage33261-826-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage33261-826-60834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage33261-826-90834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage33261-826-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage33261-826-601332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage33261-826-901332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage33261-826-301332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077995-001BICALUTAMIDEBICALUTAMIDE50MGTABLET / ORAL2009-07-06

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-0684e616aacf4f…
2026-08-18 06:07:402026-07A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-063f01610625f2…
2019-09-15 20:21 UTC2019-09A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077995-001BICALUTAMIDE50MGTABLET / ORAL2009-07-06f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

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

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-826-30Amlodipine Besylate30 in 1 BOTTLE, PLASTICTABLET301
33261-826-60Amlodipine Besylate60 in 1 BOTTLE, PLASTICTABLET601
33261-826-90Amlodipine Besylate90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-826-30EA - Each33261-826090c4dfb-6ff3-4ad5-bc4d-f78b7419425412015-10-02
33261-826-60EA - Each33261-8266309280d-d89c-476c-a8cc-390c24c4414412015-10-02
33261-826-90EA - Each33261-82620e6461e-63ad-4d04-9e91-06dcf0c4b97c12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-826AMLODIPINE BESYLATE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20140321_51e87d92-0c8a-46fa-a2d6-a8abf555201f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN51e87d92-0c8a-46fa-a2d6-a8abf555201f1
308136amLODIPine besylate 2.5 MG Oral TabletPSN51e87d92-0c8a-46fa-a2d6-a8abf555201f1
197361amLODIPine besylate 5 MG Oral TabletPSN51e87d92-0c8a-46fa-a2d6-a8abf555201f1
308135amlodipine 10 MG Oral TabletSCD51e87d92-0c8a-46fa-a2d6-a8abf555201f1
308136amlodipine 2.5 MG Oral TabletSCD51e87d92-0c8a-46fa-a2d6-a8abf555201f1
197361amlodipine 5 MG Oral TabletSCD51e87d92-0c8a-46fa-a2d6-a8abf555201f1
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY51e87d92-0c8a-46fa-a2d6-a8abf555201f1
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY51e87d92-0c8a-46fa-a2d6-a8abf555201f1
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY51e87d92-0c8a-46fa-a2d6-a8abf555201f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-826-303326108263030 in 1 BOTTLE, PLASTICHistorical
33261-826-603326108266060 in 1 BOTTLE, PLASTICHistorical
33261-826-903326108269090 in 1 BOTTLE, PLASTICHistorical