FDA.reportPublic FDA data

AMLODIPINE BESYLATE

Product NDC
61919-814
11-digit product format
619190814
Labeler code
61919
Product ID
61919-814_d28f1c26-a799-f138-e053-2995a90ad87a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMLODIPINE BESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA077073
Marketing category
ANDA
Marketing start
2019-04-29
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE
Active strength
5 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

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
61919-814-302025-01-30C16284748780-12cef2736-655a-d83d-e063-dadaa90ab31fAMLODIPINE BESYLATE
61919-814-602025-01-30C16284748780-12cef2736-655a-d83d-e063-dadaa90ab31fAMLODIPINE BESYLATE
61919-814-902025-01-30C16284748780-12cef2736-655a-d83d-e063-dadaa90ab31fAMLODIPINE BESYLATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-814-30AMLODIPINE BESYLATE30 in 1 BOTTLETABLET306
61919-814-60AMLODIPINE BESYLATE60 in 1 BOTTLETABLET606
61919-814-90AMLODIPINE BESYLATE90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-814-60EA - Each61919-8148bb1f637-a910-41b8-b66d-0a468ebaaff312022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-814AMLODIPINE BESYLATE TABLET [DIRECT RX]6Legacy NDC, 3 package rows20211208_4910c9c2-d290-38c4-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN4910c9c2-d290-38c4-e054-00144ff8d46c6
197361amLODIPine besylate 5 MG Oral TabletPSN4910c9c2-d290-38c4-e054-00144ff8d46c6
308135amlodipine 10 MG Oral TabletSCD4910c9c2-d290-38c4-e054-00144ff8d46c6
197361amlodipine 5 MG Oral TabletSCD4910c9c2-d290-38c4-e054-00144ff8d46c6
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY4910c9c2-d290-38c4-e054-00144ff8d46c6
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY4910c9c2-d290-38c4-e054-00144ff8d46c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-814-306191908143030 TABLET in 1 BOTTLE (61919-814-30) 30 tablet2019-04-290000-00-00NoNoCurrent
61919-814-606191908146060 TABLET in 1 BOTTLE (61919-814-60) 60 tablet2019-04-290000-00-00NoNoCurrent
61919-814-906191908149090 TABLET in 1 BOTTLE (61919-814-90) 90 tablet2019-04-290000-00-00NoNoCurrent