FDA.reportPublic FDA data

AMLODIPINE BESYLATE

Product NDC
42582-313
Requested package NDC
42582-313-18
11-digit product format
425820313
Labeler code
42582
Product ID
42582-313_fbea5b50-8303-4614-8dcc-40b761ea17b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMLODIPINE BESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
Bi-Coastal Pharma International LLC
Application
ANDA077516
Marketing category
ANDA
Marketing start
2016-10-05
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
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage42582-31342582-313-18IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077516-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2007-07-11a50c72e98297…
2026-08-01 22:54:322026-06A077516-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2007-07-11a50c72e98297…
2026-08-01 22:54:322026-06A077516-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2007-07-11a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMLODIPINE BESYLATEAMLODIPINE BESYLATEBryant Ranch Prepackcb3da88f-cee0-4c22-9760-a50edc8fc1402023-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077516
application number: ANDA077516

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
42582-313-092023-01-30C16284748780-1f386c64a-3ba5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP AMLODIPINE BESYLATE TABLETS, USP for oral administration Initial U.S. Approval: 1992
42582-313-182023-01-30C16284748780-1f386c64a-3ba5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP AMLODIPINE BESYLATE TABLETS, USP for oral administration Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42582-313-09AMLODIPINE BESYLATE2.5 mg90 in 1 BOTTLETABLET903
42582-313-18AMLODIPINE BESYLATE2.5 mg500 in 1 BOTTLETABLET5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42582-313-09EA - Each42582-31354e0b968-2f97-430e-be42-8c1d7350418e12018-05-09
42582-313-18EA - Each42582-313dee7d5fb-8a8a-47e5-8469-46a7ec7715b712018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42582-313AMLODIPINE BESYLATE 2.5 MG (AMLODIPINE BESYLATE) TABLET AMLODIPINE BESYLATE 5 MG (AMLODIPINE BESYLATE) TABLET AMLODIPINE BESYLATE 10 MG (AMLODIPINE BESYLATE) TABLET [BI‐COASTAL PHARMA INTERNATIONAL LLC]3Legacy NDC, 2 package rows20190109_705d4471-b1bc-49a7-a871-9c03f886b69e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN705d4471-b1bc-49a7-a871-9c03f886b69e3
308136amLODIPine besylate 2.5 MG Oral TabletPSN705d4471-b1bc-49a7-a871-9c03f886b69e3
197361amLODIPine besylate 5 MG Oral TabletPSN705d4471-b1bc-49a7-a871-9c03f886b69e3
308135amlodipine 10 MG Oral TabletSCD705d4471-b1bc-49a7-a871-9c03f886b69e3
308136amlodipine 2.5 MG Oral TabletSCD705d4471-b1bc-49a7-a871-9c03f886b69e3
197361amlodipine 5 MG Oral TabletSCD705d4471-b1bc-49a7-a871-9c03f886b69e3
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY705d4471-b1bc-49a7-a871-9c03f886b69e3
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY705d4471-b1bc-49a7-a871-9c03f886b69e3
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY705d4471-b1bc-49a7-a871-9c03f886b69e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42582-313-1842582031318500 TABLET in 1 BOTTLE (42582-313-18) 500 tablet2016-10-050000-00-00NoNoCurrent