FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
68071-3698
11-digit product format
680713698
Labeler code
68071
Product ID
68071-3698_37774bf3-6b24-06e6-e063-6294a90a5966
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA078043
Marketing category
ANDA
Marketing start
2018-08-15
Substance
AMLODIPINE BESYLATE
Active strength
10 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 BESYLATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii864V2Q084H
Rxcui308135

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
68071-3698-2Amlodipine Besylate120 in 1 BOTTLETABLET1203
68071-3698-6Amlodipine Besylate60 in 1 BOTTLETABLET603
68071-3698-9Amlodipine Besylate90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3698AMLODIPINE BESYLATE TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 3 package rows20250306_2437a130-d544-6db4-e063-6394a90a0d4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN2437a130-d544-6db4-e063-6394a90a0d4d3
308135amlodipine 10 MG Oral TabletSCD2437a130-d544-6db4-e063-6394a90a0d4d3
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY2437a130-d544-6db4-e063-6394a90a0d4d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3698-268071369802120 TABLET in 1 BOTTLE (68071-3698-2) 120 tablet2025-01-21NoNoCurrent
68071-3698-66807136980660 TABLET in 1 BOTTLE (68071-3698-6) 60 tablet2024-10-11NoNoCurrent
68071-3698-96807136980990 TABLET in 1 BOTTLE (68071-3698-9) 90 tablet2024-10-11NoNoCurrent