FDA.reportPublic FDA data

AMLODIPINE BESYLATE

Product NDC
68788-8627
11-digit product format
687888627
Labeler code
68788
Product ID
68788-8627_1941fbe2-32c3-4374-b0e2-fce704333fc8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMLODIPINE BESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077073
Marketing category
ANDA
Marketing start
2024-04-10
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
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 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
68788-8627-1AMLODIPINE BESYLATE100 in 1 BOTTLETABLET1003
68788-8627-3AMLODIPINE BESYLATE30 in 1 BOTTLETABLET303
68788-8627-6AMLODIPINE BESYLATE60 in 1 BOTTLETABLET603
68788-8627-9AMLODIPINE BESYLATE90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8627-1EA - Each68788-8627d9b6cf0d-c3da-4cd0-af94-c1602843d87f12024-06-10
68788-8627-3EA - Each68788-8627b3b3979a-23b9-44d8-8f26-ed2d2fb3790612024-06-10
68788-8627-6EA - Each68788-862717ab24ef-0c85-42d0-9d23-a5e084c32e2812024-06-10
68788-8627-9EA - Each68788-86276f3ed20e-0366-43f2-83b5-34761cbd693212024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8627AMLODIPINE BESYLATE TABLET [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 4 package rows20250124_aec7618e-c9da-431f-8b6a-14aa399242f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197361amLODIPine besylate 5 MG Oral TabletPSNaec7618e-c9da-431f-8b6a-14aa399242f63
197361amlodipine 5 MG Oral TabletSCDaec7618e-c9da-431f-8b6a-14aa399242f63
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYaec7618e-c9da-431f-8b6a-14aa399242f63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8627-168788862701100 TABLET in 1 BOTTLE (68788-8627-1) 100 tablet2024-04-10NoNoHistorical
68788-8627-36878886270330 TABLET in 1 BOTTLE (68788-8627-3) 30 tablet2024-04-10NoNoHistorical
68788-8627-66878886270660 TABLET in 1 BOTTLE (68788-8627-6) 60 tablet2024-04-10NoNoHistorical
68788-8627-96878886270990 TABLET in 1 BOTTLE (68788-8627-9) 90 tablet2024-04-10NoNoHistorical