FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
68788-8263
11-digit product format
687888263
Labeler code
68788
Product ID
68788-8263_82763ec1-d23c-4321-b825-c93fd8600bdd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine besylate
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078925
Marketing category
ANDA
Marketing start
2022-09-19
Substance
AMLODIPINE BESYLATE
Active strength
2.5 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amlodipine Besylate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii864V2Q084H
Rxcui308136

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
68788-8263-1Amlodipine Besylate100 in 1 BOTTLETABLET1005
68788-8263-3Amlodipine Besylate30 in 1 BOTTLETABLET305
68788-8263-6Amlodipine Besylate60 in 1 BOTTLETABLET605
68788-8263-9Amlodipine Besylate90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8263-1EA - Each68788-826358ab20d7-c896-432e-8dc2-2886487b40b212022-10-06
68788-8263-3EA - Each68788-8263db776311-4c39-4ef5-8985-0af6d896648012022-10-06
68788-8263-6EA - Each68788-82636b478f62-0785-4370-b219-5325ed62ce3512022-10-06
68788-8263-9EA - Each68788-82633004e396-86cf-40e2-968a-8aef9672976a12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8263AMLODIPINE BESYLATE TABLET [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 4 package rows20250124_1ff04bd2-9926-48a4-9afc-eab0789dba01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308136amLODIPine besylate 2.5 MG Oral TabletPSN1ff04bd2-9926-48a4-9afc-eab0789dba015
308136amlodipine 2.5 MG Oral TabletSCD1ff04bd2-9926-48a4-9afc-eab0789dba015
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY1ff04bd2-9926-48a4-9afc-eab0789dba015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8263-168788826301100 TABLET in 1 BOTTLE (68788-8263-1) 100 tablet2022-09-190000-00-00NoNoCurrent
68788-8263-36878882630330 TABLET in 1 BOTTLE (68788-8263-3) 30 tablet2022-09-190000-00-00NoNoCurrent
68788-8263-66878882630660 TABLET in 1 BOTTLE (68788-8263-6) 60 tablet2022-09-190000-00-00NoNoCurrent
68788-8263-96878882630990 TABLET in 1 BOTTLE (68788-8263-9) 90 tablet2022-09-190000-00-00NoNoCurrent