FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
69150-115
Requested package NDC
69150-115-05
11-digit product format
691500115
Labeler code
69150
Product ID
69150-115_f85efa7d-67e6-443a-bfca-f0c4a39af8f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
BIOMES PHARMACEUTICALS LLC
Application
ANDA077516
Marketing category
ANDA
Marketing start
2011-04-15
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE
Active strength
10 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage69150-11569150-115-05IInactivated 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
69150-115-012023-01-30C16284748780-19d75b9d0-e638-f424-e053-dadaa90a57ceThese 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These 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.<br><br>AMLODIPINE BESYL
69150-115-032023-01-30C16284748780-19d75b9d0-e638-f424-e053-dadaa90a57ceThese 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These 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.<br><br>AMLODIPINE BESYL
69150-115-052023-01-30C16284748780-19d75b9d0-e638-f424-e053-dadaa90a57ceThese 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These 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.<br><br>AMLODIPINE BESYL
69150-115-102023-01-30C16284748780-19d75b9d0-e638-f424-e053-dadaa90a57ceThese 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These 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.<br><br>AMLODIPINE BESYL
69150-115-902023-01-30C16284748780-19d75b9d0-e638-f424-e053-dadaa90a57ceThese 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These 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.<br><br>AMLODIPINE BESYL
69150-115-012021-01-15C16284748780-19d75b9d0-e638-f424-e053-dadaa90a57ceThese 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These 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.<br><br>AMLODIPINE BESYL
69150-115-032021-01-15C16284748780-19d75b9d0-e638-f424-e053-dadaa90a57ceThese 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These 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.<br><br>AMLODIPINE BESYL
69150-115-052021-01-15C16284748780-19d75b9d0-e638-f424-e053-dadaa90a57ceThese 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These 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.<br><br>AMLODIPINE BESYL
69150-115-102021-01-15C16284748780-19d75b9d0-e638-f424-e053-dadaa90a57ceThese 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These 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.<br><br>AMLODIPINE BESYL
69150-115-902021-01-15C16284748780-19d75b9d0-e638-f424-e053-dadaa90a57ceThese 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These 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.<br><br>AMLODIPINE BESYL
69150-115-012020-01-31C16284748780-19d75b9d0-e638-f424-e053-dadaa90a57ceThese 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These 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.<br><br>AMLODIPINE BESYL
69150-115-032020-01-31C16284748780-19d75b9d0-e638-f424-e053-dadaa90a57ceThese 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These 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.<br><br>AMLODIPINE BESYL
69150-115-052020-01-31C16284748780-19d75b9d0-e638-f424-e053-dadaa90a57ceThese 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These 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.<br><br>AMLODIPINE BESYL
69150-115-102020-01-31C16284748780-19d75b9d0-e638-f424-e053-dadaa90a57ceThese 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These 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.<br><br>AMLODIPINE BESYL
69150-115-902020-01-31C16284748780-19d75b9d0-e638-f424-e053-dadaa90a57ceThese 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.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These 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.<br><br>AMLODIPINE BESYL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69150-115-01Amlodipine Besylate100 in 1 BOTTLETABLET1006
69150-115-03Amlodipine Besylate300 in 1 BOTTLETABLET3006
69150-115-05Amlodipine Besylate500 in 1 BOTTLETABLET5006
69150-115-10Amlodipine Besylate1000 in 1 BOTTLETABLET10006
69150-115-90Amlodipine Besylate90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69150-115-01EA - Each69150-11561ae164f-1bfd-4340-8f75-477d0bfbad2c12016-04-04
69150-115-10EA - Each69150-115ae843cde-9b2d-40c0-b744-6c7f2ae42c1c12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69150-115AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [BIOMES PHARMACEUTICALS LLC]6Legacy NDC, 5 package rows20210116_829aad05-7f21-41c2-b80b-2da793ae70d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN829aad05-7f21-41c2-b80b-2da793ae70d76
308136amLODIPine besylate 2.5 MG Oral TabletPSN829aad05-7f21-41c2-b80b-2da793ae70d76
197361amLODIPine besylate 5 MG Oral TabletPSN829aad05-7f21-41c2-b80b-2da793ae70d76
308135amlodipine 10 MG Oral TabletSCD829aad05-7f21-41c2-b80b-2da793ae70d76
308136amlodipine 2.5 MG Oral TabletSCD829aad05-7f21-41c2-b80b-2da793ae70d76
197361amlodipine 5 MG Oral TabletSCD829aad05-7f21-41c2-b80b-2da793ae70d76
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY829aad05-7f21-41c2-b80b-2da793ae70d76
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY829aad05-7f21-41c2-b80b-2da793ae70d76
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY829aad05-7f21-41c2-b80b-2da793ae70d76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69150-115-0569150011505500 TABLET in 1 BOTTLE (69150-115-05) 500 tablet2018-07-250000-00-00NoNoCurrent