FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
71610-928
11-digit product format
716100928
Labeler code
71610
Product ID
71610-928_4910735f-515a-6896-e063-6294a90a3e7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
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
Rxcui308135

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
71610-928-30Amlodipine Besylate30 in 1 BOTTLETABLET302
71610-928-45Amlodipine Besylate45 in 1 BOTTLETABLET452
71610-928-53Amlodipine Besylate60 in 1 BOTTLETABLET602
71610-928-60Amlodipine Besylate90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-928-30EA - Each71610-928d0e701f5-8525-41cc-82f8-8ac6014e860912025-09-12
71610-928-45EA - Each71610-928ac2df35d-7fd5-40cd-a1f9-6393f5cebf7e12025-09-12
71610-928-53EA - Each71610-928a2c28e87-b2cf-48c8-880b-4a6121c6c11a12025-09-12
71610-928-60EA - Each71610-928b1d7513e-8bd0-4a80-a0d7-c8f9589c01bd12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN3ab4ad3d-7795-058a-e063-6294a90abc862
308135amlodipine 10 MG Oral TabletSCD3ab4ad3d-7795-058a-e063-6294a90abc862
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY3ab4ad3d-7795-058a-e063-6294a90abc862

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-928-307161009283030 TABLET in 1 BOTTLE (71610-928-30) 30 tablet2025-07-23NoNoHistorical
71610-928-457161009284545 TABLET in 1 BOTTLE (71610-928-45) 45 tablet2025-07-23NoNoHistorical
71610-928-537161009285360 TABLET in 1 BOTTLE (71610-928-53) 60 tablet2025-07-23NoNoHistorical
71610-928-607161009286090 TABLET in 1 BOTTLE (71610-928-60) 90 tablet2026-01-23NoNoHistorical