FDA.reportPublic FDA data

AMLODIPINE BESYLATE

Product NDC
72189-162
11-digit product format
721890162
Labeler code
72189
Product ID
72189-162_2be94c25-4a48-39f0-e063-6294a90ab40c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMLODIPINE BESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA078925
Marketing category
ANDA
Marketing start
2021-01-12
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
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 BESYLATE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN1SN99T69T, 864V2Q084H
Rxcui308136, 898342

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
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product name120150316
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
b9fbc696-7d55-c52e-4f12-7e3d99cd2db4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-162-90AMLODIPINE BESYLATE90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-162AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULE AMLODIPINE BESYLATE TABLET [DIRECT RX]3Current NDC, Legacy NDC, 1 package rows20250119_b8b9a3cd-c4e7-dfeb-e053-2a95a90aa719.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898342amLODIPine besylate 10 MG / benazepril HCl 20 MG Oral CapsulePSNb8b9a3cd-c4e7-dfeb-e053-2a95a90aa7193
308136amLODIPine besylate 2.5 MG Oral TabletPSNb8b9a3cd-c4e7-dfeb-e053-2a95a90aa7193
898342amlodipine 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSCDb8b9a3cd-c4e7-dfeb-e053-2a95a90aa7193
308136amlodipine 2.5 MG Oral TabletSCDb8b9a3cd-c4e7-dfeb-e053-2a95a90aa7193
898342amlodipine (as amlodipine besylate) 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSYb8b9a3cd-c4e7-dfeb-e053-2a95a90aa7193
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSYb8b9a3cd-c4e7-dfeb-e053-2a95a90aa7193
898342Amlodipine 10 MG / BZP hydrochloride 20 MG Oral CapsuleSYb8b9a3cd-c4e7-dfeb-e053-2a95a90aa7193

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-162-907218901629090 TABLET in 1 BOTTLE (72189-162-90) 90 tablet2021-01-120000-00-00NoNoCurrent