FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
71335-3126
11-digit product format
713353126
Labeler code
71335
Product ID
71335-3126_2abdb000-40fa-48e8-8e70-c4ebd885d810
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine besylate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078925
Marketing category
ANDA
Marketing start
2025-12-06
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
71335-3126-1Amlodipine Besylate30 in 1 BOTTLETABLET301
71335-3126-2Amlodipine Besylate90 in 1 BOTTLETABLET901
71335-3126-3Amlodipine Besylate120 in 1 BOTTLETABLET1201
71335-3126-4Amlodipine Besylate60 in 1 BOTTLETABLET601
71335-3126-5Amlodipine Besylate500 in 1 BOTTLETABLET5001
71335-3126-6Amlodipine Besylate10 in 1 BOTTLETABLET101
71335-3126-7Amlodipine Besylate100 in 1 BOTTLETABLET1001
71335-3126-8Amlodipine Besylate180 in 1 BOTTLETABLET1801

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308136amLODIPine besylate 2.5 MG Oral TabletPSN72dafc2f-5266-442b-914a-61d1ef1f7ab81
308136amlodipine 2.5 MG Oral TabletSCD72dafc2f-5266-442b-914a-61d1ef1f7ab81
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY72dafc2f-5266-442b-914a-61d1ef1f7ab81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3126-17133531260130 TABLET in 1 BOTTLE (71335-3126-1) 30 tablet2026-04-29NoNoHistorical
71335-3126-27133531260290 TABLET in 1 BOTTLE (71335-3126-2) 90 tablet2026-04-29NoNoHistorical
71335-3126-371335312603120 TABLET in 1 BOTTLE (71335-3126-3) 120 tablet2026-04-29NoNoHistorical
71335-3126-47133531260460 TABLET in 1 BOTTLE (71335-3126-4) 60 tablet2026-04-29NoNoHistorical
71335-3126-571335312605500 TABLET in 1 BOTTLE (71335-3126-5) 500 tablet2026-04-29NoNoHistorical
71335-3126-67133531260610 TABLET in 1 BOTTLE (71335-3126-6) 10 tablet2026-04-29NoNoHistorical
71335-3126-771335312607100 TABLET in 1 BOTTLE (71335-3126-7) 100 tablet2026-04-29NoNoHistorical
71335-3126-871335312608180 TABLET in 1 BOTTLE (71335-3126-8) 180 tablet2026-04-29NoNoHistorical