FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
72789-516
11-digit product format
727890516
Labeler code
72789
Product ID
72789-516_5118f5b1-9768-ddc2-e063-6394a90a4b58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA076719
Marketing category
ANDA
Marketing start
2007-05-23
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
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 BESYLATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii864V2Q084H
Rxcui197361, 308135, 308136

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
72789-516-30Amlodipine Besylate30 in 1 BOTTLE, PLASTICTABLET309
72789-516-90Amlodipine Besylate90 in 1 BOTTLE, PLASTICTABLET909
72789-516-95Amlodipine Besylate1000 in 1 BOTTLE, PLASTICTABLET10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-516-30EA - Each72789-51642ac71e3-fcc7-485e-86f7-ecffad4808a212025-10-14
72789-516-90EA - Each72789-51643c84c5d-cf4b-4313-a474-82a8ad67833212025-12-16
72789-516-95EA - Each72789-516d34233a4-5cfd-4197-92c8-ec1a3bbf0df712025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN5a0b3dd4-91f5-4173-a992-e91b1cac6a189
308136amLODIPine besylate 2.5 MG Oral TabletPSN5a0b3dd4-91f5-4173-a992-e91b1cac6a189
197361amLODIPine besylate 5 MG Oral TabletPSN5a0b3dd4-91f5-4173-a992-e91b1cac6a189
308135amlodipine 10 MG Oral TabletSCD5a0b3dd4-91f5-4173-a992-e91b1cac6a189
308136amlodipine 2.5 MG Oral TabletSCD5a0b3dd4-91f5-4173-a992-e91b1cac6a189
197361amlodipine 5 MG Oral TabletSCD5a0b3dd4-91f5-4173-a992-e91b1cac6a189
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY5a0b3dd4-91f5-4173-a992-e91b1cac6a189
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY5a0b3dd4-91f5-4173-a992-e91b1cac6a189
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY5a0b3dd4-91f5-4173-a992-e91b1cac6a189
308135amLODIPine besylate 10 MG Oral TabletPSN4a2bba2d-9b7a-f43a-e063-6294a90af80e1
308135amlodipine 10 MG Oral TabletSCD4a2bba2d-9b7a-f43a-e063-6294a90af80e1
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY4a2bba2d-9b7a-f43a-e063-6294a90af80e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-516-307278905163030 TABLET in 1 BOTTLE, PLASTIC (72789-516-30) 30 tablet2025-09-30NoNoHistorical
72789-516-907278905169090 TABLET in 1 BOTTLE, PLASTIC (72789-516-90) 90 tablet2025-10-27NoNoHistorical
72789-516-95727890516951000 TABLET in 1 BOTTLE, PLASTIC (72789-516-95) 1000 tablet2025-06-26NoNoHistorical