FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
67877-198
11-digit product format
678770198
Labeler code
67877
Product ID
67877-198_9fb4b641-2b16-4bcb-89de-d8d5893916ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine besylate
Dosage form
TABLET
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA078925
Marketing category
ANDA
Marketing start
2010-10-20
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
67877-198-05Amlodipine Besylate500 in 1 BOTTLETABLET50020
67877-198-10Amlodipine Besylate1000 in 1 BOTTLETABLET100020
67877-198-38Amlodipine Besylate10 in 1 CARTONTABLET1020
67877-198-38Amlodipine Besylate10 in 1 BLISTER PACKTABLET1020
67877-198-90Amlodipine Besylate90 in 1 BOTTLETABLET9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-198-05EA - Each67877-1986b53d674-db6e-43eb-9033-8fec8ad491ac12012-07-24
67877-198-10EA - Each67877-198e72926c0-18e8-4ec3-a1c1-317c338d40d112012-07-24
67877-198-90EA - Each67877-198326b9694-5946-402a-ad52-a01845f6f8c612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [PD-RX PHARMACEUTICALS, INC.]8
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [PD-RX PHARMACEUTICALS, INC.]8
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET [PD-RX PHARMACEUTICALS, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [PD-RX PHARMACEUTICALS, INC.]8
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE TABLET [PD-RX PHARMACEUTICALS, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [PD-RX PHARMACEUTICALS, INC.]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [PD-RX PHARMACEUTICALS, INC.]8
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [ASCEND LABORATORIES, LLC]6
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [ASCEND LABORATORIES, LLC]6
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET [ASCEND LABORATORIES, LLC]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [ASCEND LABORATORIES, LLC]6
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE TABLET [ASCEND LABORATORIES, LLC]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [ASCEND LABORATORIES, LLC]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [ASCEND LABORATORIES, LLC]6
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [PREFERRED PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-198AMLODIPINE BESYLATE TABLET [ASCEND LABORATORIES, LLC]20Current NDC, Legacy NDC, 5 package rows20240622_3f4703c0-0b9e-41a0-8b70-da26683d9ed2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN921096ab-589a-4821-8d91-a6319f4a559a35
308136amLODIPine besylate 2.5 MG Oral TabletPSN921096ab-589a-4821-8d91-a6319f4a559a35
197361amLODIPine besylate 5 MG Oral TabletPSN921096ab-589a-4821-8d91-a6319f4a559a35
308135amlodipine 10 MG Oral TabletSCD921096ab-589a-4821-8d91-a6319f4a559a35
308136amlodipine 2.5 MG Oral TabletSCD921096ab-589a-4821-8d91-a6319f4a559a35
197361amlodipine 5 MG Oral TabletSCD921096ab-589a-4821-8d91-a6319f4a559a35
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY921096ab-589a-4821-8d91-a6319f4a559a35
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY921096ab-589a-4821-8d91-a6319f4a559a35
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY921096ab-589a-4821-8d91-a6319f4a559a35
197361amLODIPine besylate 5 MG Oral TabletPSNac0dd8fb-ebe1-4d02-bd0d-4f979c6e360833
197361amlodipine 5 MG Oral TabletSCDac0dd8fb-ebe1-4d02-bd0d-4f979c6e360833
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYac0dd8fb-ebe1-4d02-bd0d-4f979c6e360833
308135amLODIPine besylate 10 MG Oral TabletPSN3f4703c0-0b9e-41a0-8b70-da26683d9ed220
308136amLODIPine besylate 2.5 MG Oral TabletPSN3f4703c0-0b9e-41a0-8b70-da26683d9ed220
197361amLODIPine besylate 5 MG Oral TabletPSN3f4703c0-0b9e-41a0-8b70-da26683d9ed220
308135amlodipine 10 MG Oral TabletSCD3f4703c0-0b9e-41a0-8b70-da26683d9ed220
308136amlodipine 2.5 MG Oral TabletSCD3f4703c0-0b9e-41a0-8b70-da26683d9ed220
197361amlodipine 5 MG Oral TabletSCD3f4703c0-0b9e-41a0-8b70-da26683d9ed220
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY3f4703c0-0b9e-41a0-8b70-da26683d9ed220
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY3f4703c0-0b9e-41a0-8b70-da26683d9ed220
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY3f4703c0-0b9e-41a0-8b70-da26683d9ed220
197361amLODIPine besylate 5 MG Oral TabletPSN204f27e9-5041-4677-b313-866ca69abad917
197361amlodipine 5 MG Oral TabletSCD204f27e9-5041-4677-b313-866ca69abad917
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY204f27e9-5041-4677-b313-866ca69abad917
308135amLODIPine besylate 10 MG Oral TabletPSN47f228e9-4a34-4d14-988d-b06af90124b916
308136amLODIPine besylate 2.5 MG Oral TabletPSN47f228e9-4a34-4d14-988d-b06af90124b916
197361amLODIPine besylate 5 MG Oral TabletPSN47f228e9-4a34-4d14-988d-b06af90124b916
308135amlodipine 10 MG Oral TabletSCD47f228e9-4a34-4d14-988d-b06af90124b916
308136amlodipine 2.5 MG Oral TabletSCD47f228e9-4a34-4d14-988d-b06af90124b916
197361amlodipine 5 MG Oral TabletSCD47f228e9-4a34-4d14-988d-b06af90124b916
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY47f228e9-4a34-4d14-988d-b06af90124b916
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY47f228e9-4a34-4d14-988d-b06af90124b916
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY47f228e9-4a34-4d14-988d-b06af90124b916
197361amLODIPine besylate 5 MG Oral TabletPSN01139e81-a4fa-4e13-acdf-c75c79a1aa9c12
197361amlodipine 5 MG Oral TabletSCD01139e81-a4fa-4e13-acdf-c75c79a1aa9c12
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY01139e81-a4fa-4e13-acdf-c75c79a1aa9c12
308135amLODIPine besylate 10 MG Oral TabletPSN6cf5ece4-4d4e-478e-be8f-bd198c6edc5d11
308135amLODIPine besylate 10 MG Oral TabletPSN6b7c18ef-3a85-4ae3-9135-7ac30a0dde0811
308136amLODIPine besylate 2.5 MG Oral TabletPSN6cf5ece4-4d4e-478e-be8f-bd198c6edc5d11
197361amLODIPine besylate 5 MG Oral TabletPSN6cf5ece4-4d4e-478e-be8f-bd198c6edc5d11
197361amLODIPine besylate 5 MG Oral TabletPSN6b7c18ef-3a85-4ae3-9135-7ac30a0dde0811
308135amlodipine 10 MG Oral TabletSCD6cf5ece4-4d4e-478e-be8f-bd198c6edc5d11
308135amlodipine 10 MG Oral TabletSCD6b7c18ef-3a85-4ae3-9135-7ac30a0dde0811
308136amlodipine 2.5 MG Oral TabletSCD6cf5ece4-4d4e-478e-be8f-bd198c6edc5d11
197361amlodipine 5 MG Oral TabletSCD6cf5ece4-4d4e-478e-be8f-bd198c6edc5d11
197361amlodipine 5 MG Oral TabletSCD6b7c18ef-3a85-4ae3-9135-7ac30a0dde0811
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY6cf5ece4-4d4e-478e-be8f-bd198c6edc5d11
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY6b7c18ef-3a85-4ae3-9135-7ac30a0dde0811
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY6cf5ece4-4d4e-478e-be8f-bd198c6edc5d11
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY6cf5ece4-4d4e-478e-be8f-bd198c6edc5d11
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY6b7c18ef-3a85-4ae3-9135-7ac30a0dde0811
308135amLODIPine besylate 10 MG Oral TabletPSN1b449c22-0181-4a50-94b3-26139b90b9789
197361amLODIPine besylate 5 MG Oral TabletPSN1b449c22-0181-4a50-94b3-26139b90b9789
308135amlodipine 10 MG Oral TabletSCD1b449c22-0181-4a50-94b3-26139b90b9789
197361amlodipine 5 MG Oral TabletSCD1b449c22-0181-4a50-94b3-26139b90b9789
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY1b449c22-0181-4a50-94b3-26139b90b9789
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY1b449c22-0181-4a50-94b3-26139b90b9789
197361amLODIPine besylate 5 MG Oral TabletPSN638d86ab-986b-59ed-e053-2a91aa0a98ee6
197361amLODIPine besylate 5 MG Oral TabletPSN8904ea3a-be04-5cdb-e053-2a95a90aad7f6
197361amLODIPine besylate 5 MG Oral TabletPSN3f74ed2b-4712-4026-ac2c-9239a211dde36
197361amlodipine 5 MG Oral TabletSCD638d86ab-986b-59ed-e053-2a91aa0a98ee6
197361amlodipine 5 MG Oral TabletSCD8904ea3a-be04-5cdb-e053-2a95a90aad7f6
197361amlodipine 5 MG Oral TabletSCD3f74ed2b-4712-4026-ac2c-9239a211dde36
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY8904ea3a-be04-5cdb-e053-2a95a90aad7f6
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY3f74ed2b-4712-4026-ac2c-9239a211dde36
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY638d86ab-986b-59ed-e053-2a91aa0a98ee6
308135amLODIPine besylate 10 MG Oral TabletPSN44f7e13f-b90f-477b-86cf-21667d90f9a95
197361amLODIPine besylate 5 MG Oral TabletPSN44f7e13f-b90f-477b-86cf-21667d90f9a95
197361amLODIPine besylate 5 MG Oral TabletPSN4512feee-a09d-4244-bc03-c43193e53a0e5
308135amlodipine 10 MG Oral TabletSCD44f7e13f-b90f-477b-86cf-21667d90f9a95
197361amlodipine 5 MG Oral TabletSCD44f7e13f-b90f-477b-86cf-21667d90f9a95
197361amlodipine 5 MG Oral TabletSCD4512feee-a09d-4244-bc03-c43193e53a0e5
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY44f7e13f-b90f-477b-86cf-21667d90f9a95
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY4512feee-a09d-4244-bc03-c43193e53a0e5
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY44f7e13f-b90f-477b-86cf-21667d90f9a95
197361amLODIPine besylate 5 MG Oral TabletPSN9c448d87-294e-3325-e053-2a95a90a22994
197361amlodipine 5 MG Oral TabletSCD9c448d87-294e-3325-e053-2a95a90a22994
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY9c448d87-294e-3325-e053-2a95a90a22994
197361amLODIPine besylate 5 MG Oral TabletPSNf2b8274b-d849-6793-e053-2a95a90aa0e83
197361amlodipine 5 MG Oral TabletSCDf2b8274b-d849-6793-e053-2a95a90aa0e83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-198-0567877019805500 TABLET in 1 BOTTLE (67877-198-05) 500 tablet2010-10-200000-00-00NoNoCurrent
67877-198-10678770198101000 TABLET in 1 BOTTLE (67877-198-10) 1000 tablet2010-10-200000-00-00NoNoCurrent
67877-198-386787701983810 BLISTER PACK in 1 CARTON (67877-198-38) / 10 TABLET in 1 BLISTER PACK10 blister pack2010-10-200000-00-00NoNoCurrent
67877-198-906787701989090 TABLET in 1 BOTTLE (67877-198-90) 90 tablet2010-10-200000-00-00NoNoCurrent