FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
55111-271
11-digit product format
551110271
Labeler code
55111
Product ID
55111-271_b1a220cd-5b4e-2660-4728-73b07ce5ed4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
Dr Reddy's Laboratories
Application
ANDA076692
Marketing category
ANDA
Marketing start
2007-07-23
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
2018-12-31
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
55111-271-012020-01-31C16284748780-19d75b9d0-2a82-f424-e053-dadaa90a57ceAmlodipine Besylate Tablets
55111-271-052020-01-31C16284748780-19d75b9d0-2a82-f424-e053-dadaa90a57ceAmlodipine Besylate Tablets
55111-271-782020-01-31C16284748780-19d75b9d0-2a82-f424-e053-dadaa90a57ceAmlodipine Besylate Tablets
55111-271-902020-01-31C16284748780-19d75b9d0-2a82-f424-e053-dadaa90a57ceAmlodipine Besylate Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-271-01Amlodipine Besylate100 in 1 BOTTLETABLET1001
55111-271-05Amlodipine Besylate500 in 1 BOTTLETABLET5001
55111-271-78Amlodipine Besylate10 in 1 CARTONTABLET101
55111-271-79Amlodipine Besylate10 in 1 BLISTER PACKTABLET101
55111-271-90Amlodipine Besylate90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-271AMLODIPINE BESYLATE TABLET [DR REDDY'S LABORATORIES]1Legacy NDC, 5 package rows20100315_5b1e1926-d2d4-8bb1-185c-f0da07247b51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN5b1e1926-d2d4-8bb1-185c-f0da07247b511
308136amLODIPine besylate 2.5 MG Oral TabletPSN5b1e1926-d2d4-8bb1-185c-f0da07247b511
197361amLODIPine besylate 5 MG Oral TabletPSN5b1e1926-d2d4-8bb1-185c-f0da07247b511
308135amlodipine 10 MG Oral TabletSCD5b1e1926-d2d4-8bb1-185c-f0da07247b511
308136amlodipine 2.5 MG Oral TabletSCD5b1e1926-d2d4-8bb1-185c-f0da07247b511
197361amlodipine 5 MG Oral TabletSCD5b1e1926-d2d4-8bb1-185c-f0da07247b511
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY5b1e1926-d2d4-8bb1-185c-f0da07247b511
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY5b1e1926-d2d4-8bb1-185c-f0da07247b511
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY5b1e1926-d2d4-8bb1-185c-f0da07247b511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55111-271-0155111027101100 in 1 BOTTLEHistorical
55111-271-0555111027105500 in 1 BOTTLEHistorical
55111-271-785511102717810 in 1 CARTONHistorical
55111-271-795511102717910 in 1 BLISTER PACKHistorical
55111-271-905511102719090 in 1 BOTTLEHistorical