FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
10544-112
11-digit product format
105440112
Labeler code
10544
Product ID
10544-112_fbeeafae-b466-42d3-8e1a-27a4626cc0c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA077955
Marketing category
ANDA
Marketing start
2012-01-18
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
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
10544-112-302020-01-31C16284748780-19d75b9d0-a77d-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. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-112-30Amlodipine Besylate30 in 1 BOTTLETABLET307

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [BLENHEIM PHARMACAL, INC.]7
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [BLENHEIM PHARMACAL, INC.]7
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET [BLENHEIM PHARMACAL, INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [BLENHEIM PHARMACAL, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [BLENHEIM PHARMACAL, INC.]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [BLENHEIM PHARMACAL, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-112AMLODIPINE BESYLATE TABLET [BLENHEIM PHARMACAL, INC.]7Legacy NDC, 1 package rows20151021_eefd43c3-028c-43d6-aa51-26d7157ea8f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSNeefd43c3-028c-43d6-aa51-26d7157ea8f37
197361amLODIPine besylate 5 MG Oral TabletPSNeefd43c3-028c-43d6-aa51-26d7157ea8f37
308135amlodipine 10 MG Oral TabletSCDeefd43c3-028c-43d6-aa51-26d7157ea8f37
197361amlodipine 5 MG Oral TabletSCDeefd43c3-028c-43d6-aa51-26d7157ea8f37
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYeefd43c3-028c-43d6-aa51-26d7157ea8f37
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYeefd43c3-028c-43d6-aa51-26d7157ea8f37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-112-301054401123030 in 1 BOTTLEHistorical