FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
64725-0238
11-digit product format
647250238
Labeler code
64725
Product ID
64725-0238_09bd05f2-2c3f-47b0-9b25-9da517dec583
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA077955
Marketing category
ANDA
Marketing start
2011-01-01
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
E
Listing certified through
2017-12-31
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
64725-0238-02019-11-27C16284748780-19855e2a2-4e8a-60a7-e053-dbdaa90a05bdAmlodipine besylate tablets These highlights do not include all the information needed to use Amlodipine Besylate safely and effectively. See full prescribing information for Amlodipine Besylate. Amlodipine Besylate (Amlodipine Besylate) TABLET for ORAL use. Initial U.S. Approval: 2007

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0238-0Amlodipine Besylate100 in 1 BOTTLETABLET1002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [TYA PHARMACEUTICALS]2
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [TYA PHARMACEUTICALS]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [TYA PHARMACEUTICALS]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0238AMLODIPINE BESYLATE TABLET [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20140927_551c5efd-9e40-4015-92f8-6fbb229b548e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197361amLODIPine besylate 5 MG Oral TabletPSN551c5efd-9e40-4015-92f8-6fbb229b548e2
197361amlodipine 5 MG Oral TabletSCD551c5efd-9e40-4015-92f8-6fbb229b548e2
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY551c5efd-9e40-4015-92f8-6fbb229b548e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-0238-064725023800100 in 1 BOTTLEHistorical