FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
50090-6876
11-digit product format
500906876
Labeler code
50090
Product ID
50090-6876_42b700b7-80e2-4224-b54b-d922e6f12dcd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203245
Marketing category
ANDA
Marketing start
2019-05-22
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

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
50090-6876-0Amlodipine Besylate30 in 1 BOTTLETABLET303
50090-6876-1Amlodipine Besylate90 in 1 BOTTLETABLET903
50090-6876-2Amlodipine Besylate100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6876-0EA - Each50090-68761e85d5ee-461e-46ef-bb2a-bb5b372db84212024-02-14
50090-6876-1EA - Each50090-6876f253a17c-ccda-4e52-84d7-620d0eda678e12024-02-14
50090-6876-2EA - Each50090-687631e7f81b-939c-4143-a859-0aac456f35ca12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6876AMLODIPINE BESYLATE TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, 3 package rows20241010_da4e36d3-1ddc-4350-9a00-86975e523f75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197361amLODIPine besylate 5 MG Oral TabletPSNda4e36d3-1ddc-4350-9a00-86975e523f753
197361amlodipine 5 MG Oral TabletSCDda4e36d3-1ddc-4350-9a00-86975e523f753
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYda4e36d3-1ddc-4350-9a00-86975e523f753

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6876-05009068760030 TABLET in 1 BOTTLE (50090-6876-0) 30 tablet2023-12-05NoNoCurrent
50090-6876-15009068760190 TABLET in 1 BOTTLE (50090-6876-1) 90 tablet2023-12-05NoNoCurrent
50090-6876-250090687602100 TABLET in 1 BOTTLE (50090-6876-2) 100 tablet2023-12-05NoNoCurrent