FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
29300-241
11-digit product format
293000241
Labeler code
29300
Product ID
29300-241_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
3 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
29300-241-05EA - Each29300-241b9f76fa3-c45a-40e7-8ebd-0e012eaf124112014-07-02
29300-241-10EA - Each29300-2417f8affe1-17e8-4040-ab88-7e051e9f894712014-07-02
29300-241-19EA - Each29300-2411a63fc1c-8bcc-4f1c-98b1-ed516f2d73ed12014-07-02

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
308136amLODIPine besylate 2.5 MG Oral TabletPSN46c9e361-39e1-6f5e-e054-00144ff8d46c2
308136amlodipine 2.5 MG Oral TabletSCD46c9e361-39e1-6f5e-e054-00144ff8d46c2
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY46c9e361-39e1-6f5e-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-241-0329300024103300 TABLET in 1 BOTTLE, PLASTIC (29300-241-03) 300 tablet2014-03-030000-00-00NoNoCurrent
29300-241-0529300024105500 TABLET in 1 BOTTLE, PLASTIC (29300-241-05) 500 tablet2014-03-030000-00-00NoNoCurrent
29300-241-10293000241101000 TABLET in 1 BOTTLE, PLASTIC (29300-241-10) 1000 tablet2014-03-030000-00-00NoNoCurrent
29300-241-192930002411990 TABLET in 1 BOTTLE, PLASTIC (29300-241-19) 90 tablet2014-03-030000-00-00NoNoCurrent