FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
68382-122
11-digit product format
683820122
Labeler code
68382
Product ID
68382-122_cd7a7360-2639-480a-af3d-0cb410c22110
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA078226
Marketing category
ANDA
Marketing start
2007-09-21
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amlodipine Besylate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii864V2Q084H
Rxcui197361, 308135, 308136

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-122-01Amlodipine Besylate100 in 1 BOTTLETABLET10019
68382-122-05Amlodipine Besylate500 in 1 BOTTLETABLET50019
68382-122-16Amlodipine Besylate90 in 1 BOTTLETABLET9019
68382-122-77Amlodipine Besylate10 in 1 BLISTER PACKTABLET1019
68382-122-77Amlodipine Besylate10 in 1 CARTONTABLET1019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-122-01EA - Each68382-12223247ce9-971a-4d33-82d7-a55167169b8c12012-07-24
68382-122-05EA - Each68382-122cba63ea3-90fb-43f2-acc2-a9262b57357d12012-07-24
68382-122-16EA - Each68382-1221759485d-f386-4aed-bb0b-ff0a1acf282f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]9
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]9
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]9
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [MAJOR PHARMACEUTICALS]1
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [MAJOR PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [MAJOR PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [MAJOR PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE TABLET [MAJOR PHARMACEUTICALS]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-122AMLODIPINE BESYLATE TABLET [ZYDUS PHARMACEUTICALS USA INC.]19Current NDC, Legacy NDC, 5 package rows20241022_fda0739d-b355-478c-acae-8f773a3ec4b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSNfda0739d-b355-478c-acae-8f773a3ec4b319
308136amLODIPine besylate 2.5 MG Oral TabletPSNfda0739d-b355-478c-acae-8f773a3ec4b319
197361amLODIPine besylate 5 MG Oral TabletPSNfda0739d-b355-478c-acae-8f773a3ec4b319
308135amlodipine 10 MG Oral TabletSCDfda0739d-b355-478c-acae-8f773a3ec4b319
308136amlodipine 2.5 MG Oral TabletSCDfda0739d-b355-478c-acae-8f773a3ec4b319
197361amlodipine 5 MG Oral TabletSCDfda0739d-b355-478c-acae-8f773a3ec4b319
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYfda0739d-b355-478c-acae-8f773a3ec4b319
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSYfda0739d-b355-478c-acae-8f773a3ec4b319
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYfda0739d-b355-478c-acae-8f773a3ec4b319
308135amLODIPine besylate 10 MG Oral TabletPSNedf9b22c-e37e-4b4e-8a64-20bb036c7d2d6
308136amLODIPine besylate 2.5 MG Oral TabletPSNedf9b22c-e37e-4b4e-8a64-20bb036c7d2d6
197361amLODIPine besylate 5 MG Oral TabletPSNedf9b22c-e37e-4b4e-8a64-20bb036c7d2d6
308135amlodipine 10 MG Oral TabletSCDedf9b22c-e37e-4b4e-8a64-20bb036c7d2d6
308136amlodipine 2.5 MG Oral TabletSCDedf9b22c-e37e-4b4e-8a64-20bb036c7d2d6
197361amlodipine 5 MG Oral TabletSCDedf9b22c-e37e-4b4e-8a64-20bb036c7d2d6
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYedf9b22c-e37e-4b4e-8a64-20bb036c7d2d6
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSYedf9b22c-e37e-4b4e-8a64-20bb036c7d2d6
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYedf9b22c-e37e-4b4e-8a64-20bb036c7d2d6
197361amLODIPine besylate 5 MG Oral TabletPSN04809c4e-ae49-4c0b-92e2-123156bd8eab1
197361amlodipine 5 MG Oral TabletSCD04809c4e-ae49-4c0b-92e2-123156bd8eab1
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY04809c4e-ae49-4c0b-92e2-123156bd8eab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-122-0168382012201100 TABLET in 1 BOTTLE (68382-122-01) 100 tablet2007-09-210000-00-00NoNoCurrent
68382-122-0568382012205500 TABLET in 1 BOTTLE (68382-122-05) 500 tablet2007-09-210000-00-00NoNoCurrent
68382-122-166838201221690 TABLET in 1 BOTTLE (68382-122-16) 90 tablet2007-09-210000-00-00NoNoCurrent
68382-122-776838201227710 BLISTER PACK in 1 CARTON (68382-122-77) / 10 TABLET in 1 BLISTER PACK10 blister pack2007-09-210000-00-00NoNoCurrent