Amlodipine Besylate

Product NDC
67296-1648
11-digit product format
672961648
Labeler code
67296
Product ID
67296-1648_b8df8208-8211-72a9-e053-2a95a90ae5cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine besylate
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA078925
Marketing category
ANDA
Marketing start
2010-10-20
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
67296-1648-32024-07-24C16284748780-1f386c649-f839-0266-e053-dadaa90a7c1aAmlodipine 5mg
67296-1648-32023-01-30C16284748780-1f386c649-f839-0266-e053-dadaa90a7c1aAmlodipine 5mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1648-3Amlodipine Besylate30 in 1 BOTTLETABLET306
67296-1648-9Amlodipine Besylate90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1648AMLODIPINE BESYLATE TABLET [REDPHARM DRUG, INC.]6Legacy NDC, 2 package rows20240725_8904ea3a-be04-5cdb-e053-2a95a90aad7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197361amLODIPine besylate 5 MG Oral TabletPSN8904ea3a-be04-5cdb-e053-2a95a90aad7f6
197361amlodipine 5 MG Oral TabletSCD8904ea3a-be04-5cdb-e053-2a95a90aad7f6
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY8904ea3a-be04-5cdb-e053-2a95a90aad7f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1648-36729616480330 TABLET in 1 BOTTLE (67296-1648-3) 30 tablet2010-10-200000-00-00NoNoCurrent
67296-1648-96729616480990 in 1 BOTTLEHistorical