FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
50090-5354
11-digit product format
500905354
Labeler code
50090
Product ID
50090-5354_ccb87248-13c9-455b-8e8e-3f21fd381cf8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078043
Marketing category
ANDA
Marketing start
2018-08-15
Substance
AMLODIPINE BESYLATE
Active strength
10 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amlodipine Besylate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii864V2Q084H
Rxcui308135

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
50090-5354-02023-02-07C16284748780-1f386c64a-1dfb-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
50090-5354-12023-02-07C16284748780-1f386c64a-1dfb-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
50090-5354-02023-01-30C16284748780-1f386c64a-1dfb-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
50090-5354-12023-01-30C16284748780-1f386c64a-1dfb-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5354-0Amlodipine Besylate30 in 1 BOTTLETABLET308
50090-5354-1Amlodipine Besylate90 in 1 BOTTLETABLET908
50090-5354-2Amlodipine Besylate100 in 1 BOTTLETABLET1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5354-0EA - Each50090-5354f0fe0f8e-ff81-49c2-91d0-9c2f3b06136812022-12-07
50090-5354-1EA - Each50090-5354ef21cd35-d711-492b-a17f-ded1624d9ee812022-01-06
50090-5354-2EA - Each50090-5354a5ccc83e-d86e-4ed0-9ecb-e22a5d2dd1c312024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5354AMLODIPINE BESYLATE TABLET [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 3 package rows20241015_3bd019d3-b58c-44ab-9190-606a0af5e9b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN3bd019d3-b58c-44ab-9190-606a0af5e9b68
308135amlodipine 10 MG Oral TabletSCD3bd019d3-b58c-44ab-9190-606a0af5e9b68
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY3bd019d3-b58c-44ab-9190-606a0af5e9b68

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5354-05009053540030 TABLET in 1 BOTTLE (50090-5354-0) 30 tablet2020-11-110000-00-00NoNoCurrent
50090-5354-15009053540190 TABLET in 1 BOTTLE (50090-5354-1) 90 tablet2020-11-110000-00-00NoNoCurrent
50090-5354-250090535402100 TABLET in 1 BOTTLE (50090-5354-2) 100 tablet2024-10-10NoNoCurrent