FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
29300-242
11-digit product format
293000242
Labeler code
29300
Product ID
29300-242_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
5 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
29300-242-05EA - Each29300-242969f415e-2b8f-43dd-8e92-47793e7dd2e812014-07-02
29300-242-10EA - Each29300-242c82b899a-f46c-48f2-8197-bf50c80ae9a412014-07-02
29300-242-19EA - Each29300-242fc1b0e7d-4624-40da-94c6-3b1ecef8d15712014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [MEDSOURCE PHARMACEUTICALS]1
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [DIRECTRX]1
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [MEDSOURCE PHARMACEUTICALS]1
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [DIRECTRX]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET [MEDSOURCE PHARMACEUTICALS]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [MEDSOURCE PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [MEDSOURCE PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [DIRECTRX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [MEDSOURCE PHARMACEUTICALS]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [DIRECTRX]1

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 TabletPSN2db18372-0600-480f-8551-533b61415abd6
197361amLODIPine besylate 5 MG Oral TabletPSN2db18372-0600-480f-8551-533b61415abd6
308135amlodipine 10 MG Oral TabletSCD2db18372-0600-480f-8551-533b61415abd6
197361amlodipine 5 MG Oral TabletSCD2db18372-0600-480f-8551-533b61415abd6
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY2db18372-0600-480f-8551-533b61415abd6
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY2db18372-0600-480f-8551-533b61415abd6
308135amLODIPine besylate 10 MG Oral TabletPSNb2ce9cd0-1c79-4b35-b87b-daff2c381a735
197361amLODIPine besylate 5 MG Oral TabletPSNb2ce9cd0-1c79-4b35-b87b-daff2c381a735
308135amlodipine 10 MG Oral TabletSCDb2ce9cd0-1c79-4b35-b87b-daff2c381a735
197361amlodipine 5 MG Oral TabletSCDb2ce9cd0-1c79-4b35-b87b-daff2c381a735
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYb2ce9cd0-1c79-4b35-b87b-daff2c381a735
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYb2ce9cd0-1c79-4b35-b87b-daff2c381a735
197361amLODIPine besylate 5 MG Oral TabletPSN56d031db-67ed-217d-e054-00144ff88e883
197361amlodipine 5 MG Oral TabletSCD56d031db-67ed-217d-e054-00144ff88e883
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY56d031db-67ed-217d-e054-00144ff88e883
197361amLODIPine besylate 5 MG Oral TabletPSNb28ff8d2-c7d2-4043-b537-78463abd765f1
197361amLODIPine besylate 5 MG Oral TabletPSN8ed46bb1-9fc9-4418-e053-2a95a90abd4b1
197361amLODIPine besylate 5 MG Oral TabletPSN46cafc45-78af-38a1-e054-00144ff88e881
197361amLODIPine besylate 5 MG Oral TabletPSN1f7dd809-74b0-366f-e054-00144ff8d46c1
197361amlodipine 5 MG Oral TabletSCDb28ff8d2-c7d2-4043-b537-78463abd765f1
197361amlodipine 5 MG Oral TabletSCD1f7dd809-74b0-366f-e054-00144ff8d46c1
197361amlodipine 5 MG Oral TabletSCD8ed46bb1-9fc9-4418-e053-2a95a90abd4b1
197361amlodipine 5 MG Oral TabletSCD46cafc45-78af-38a1-e054-00144ff88e881
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYb28ff8d2-c7d2-4043-b537-78463abd765f1
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY8ed46bb1-9fc9-4418-e053-2a95a90abd4b1
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY46cafc45-78af-38a1-e054-00144ff88e881
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY1f7dd809-74b0-366f-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-242-0329300024203300 TABLET in 1 BOTTLE, PLASTIC (29300-242-03) 300 tablet2014-03-030000-00-00NoNoCurrent
29300-242-0529300024205500 TABLET in 1 BOTTLE, PLASTIC (29300-242-05) 500 tablet2014-03-030000-00-00NoNoCurrent
29300-242-10293000242101000 TABLET in 1 BOTTLE, PLASTIC (29300-242-10) 1000 tablet2014-03-030000-00-00NoNoCurrent
29300-242-192930002421990 TABLET in 1 BOTTLE, PLASTIC (29300-242-19) 90 tablet2014-03-030000-00-00NoNoCurrent