FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
29300-243
11-digit product format
293000243
Labeler code
29300
Product ID
29300-243_cb3f3981-8d99-4d65-90cf-2bb6722167b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA203245
Marketing category
ANDA
Marketing start
2014-03-03
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE
Active strength
10 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-243-05EA - Each29300-2438482a1f4-d7ba-43a1-9f15-076b55b7e11712014-07-02
29300-243-10EA - Each29300-24340f6d5a1-80a0-47a1-a062-27a66468263912014-07-02
29300-243-19EA - Each29300-243f7e77ba7-2e09-4b8a-b160-2a2b2ed68b1212014-07-02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSNda3d696b-8db7-4487-be86-c2e8cbfbe74921
308136amLODIPine besylate 2.5 MG Oral TabletPSNda3d696b-8db7-4487-be86-c2e8cbfbe74921
197361amLODIPine besylate 5 MG Oral TabletPSNda3d696b-8db7-4487-be86-c2e8cbfbe74921
308135amlodipine 10 MG Oral TabletSCDda3d696b-8db7-4487-be86-c2e8cbfbe74921
308136amlodipine 2.5 MG Oral TabletSCDda3d696b-8db7-4487-be86-c2e8cbfbe74921
197361amlodipine 5 MG Oral TabletSCDda3d696b-8db7-4487-be86-c2e8cbfbe74921
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYda3d696b-8db7-4487-be86-c2e8cbfbe74921
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSYda3d696b-8db7-4487-be86-c2e8cbfbe74921
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYda3d696b-8db7-4487-be86-c2e8cbfbe74921
308135amLODIPine besylate 10 MG Oral TabletPSN4910c9c2-d290-38c4-e054-00144ff8d46c6
308135amLODIPine besylate 10 MG Oral TabletPSN2db18372-0600-480f-8551-533b61415abd6
197361amLODIPine besylate 5 MG Oral TabletPSN2db18372-0600-480f-8551-533b61415abd6
197361amLODIPine besylate 5 MG Oral TabletPSN4910c9c2-d290-38c4-e054-00144ff8d46c6
308135amlodipine 10 MG Oral TabletSCD2db18372-0600-480f-8551-533b61415abd6
308135amlodipine 10 MG Oral TabletSCD4910c9c2-d290-38c4-e054-00144ff8d46c6
197361amlodipine 5 MG Oral TabletSCD4910c9c2-d290-38c4-e054-00144ff8d46c6
197361amlodipine 5 MG Oral TabletSCD2db18372-0600-480f-8551-533b61415abd6
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY2db18372-0600-480f-8551-533b61415abd6
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY4910c9c2-d290-38c4-e054-00144ff8d46c6
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY4910c9c2-d290-38c4-e054-00144ff8d46c6
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY2db18372-0600-480f-8551-533b61415abd6
308135amLODIPine besylate 10 MG Oral TabletPSN48f94245-3a9d-0b7c-e054-00144ff88e883
308136amLODIPine besylate 2.5 MG Oral TabletPSN48f94245-3a9d-0b7c-e054-00144ff88e883
308135amlodipine 10 MG Oral TabletSCD48f94245-3a9d-0b7c-e054-00144ff88e883
308136amlodipine 2.5 MG Oral TabletSCD48f94245-3a9d-0b7c-e054-00144ff88e883
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY48f94245-3a9d-0b7c-e054-00144ff88e883
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY48f94245-3a9d-0b7c-e054-00144ff88e883
308135amLODIPine besylate 10 MG Oral TabletPSNc5861dd6-f0cb-449d-9ebe-53c7a76b3d002
308135amLODIPine besylate 10 MG Oral TabletPSN8ed59bcc-5840-f798-e053-2995a90a828b2
308135amlodipine 10 MG Oral TabletSCDc5861dd6-f0cb-449d-9ebe-53c7a76b3d002
308135amlodipine 10 MG Oral TabletSCD8ed59bcc-5840-f798-e053-2995a90a828b2
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY8ed59bcc-5840-f798-e053-2995a90a828b2
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYc5861dd6-f0cb-449d-9ebe-53c7a76b3d002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-243-0329300024303300 TABLET in 1 BOTTLE, PLASTIC (29300-243-03) 300 tablet2014-03-030000-00-00NoNoCurrent
29300-243-0529300024305500 TABLET in 1 BOTTLE, PLASTIC (29300-243-05) 500 tablet2014-03-030000-00-00NoNoCurrent
29300-243-10293000243101000 TABLET in 1 BOTTLE, PLASTIC (29300-243-10) 1000 tablet2014-03-030000-00-00NoNoCurrent
29300-243-192930002431990 TABLET in 1 BOTTLE, PLASTIC (29300-243-19) 90 tablet2014-03-030000-00-00NoNoCurrent