FDA.reportPublic FDA data

AMLODIPINE BESYLATE

Product NDC
71610-691
11-digit product format
716100691
Labeler code
71610
Product ID
71610-691_9417d815-3b9a-4f80-93bc-3452217d5fe9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMLODIPINE BESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078552
Marketing category
ANDA
Marketing start
2011-04-25
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
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 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
71610-691-15AMLODIPINE BESYLATE15 in 1 BOTTLETABLET152
71610-691-30AMLODIPINE BESYLATE30 in 1 BOTTLETABLET302
71610-691-45AMLODIPINE BESYLATE45 in 1 BOTTLETABLET452
71610-691-60AMLODIPINE BESYLATE90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-691-30EA - Each71610-691e1c04554-60eb-4f14-b8ce-e02f6c37163012024-01-04
71610-691-60EA - Each71610-691f583c8de-fa14-4b07-9447-4aad060c700912023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-691AMLODIPINE BESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, 4 package rows20230505_186b6149-9610-4380-9bf2-941646069276.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197361amLODIPine besylate 5 MG Oral TabletPSN186b6149-9610-4380-9bf2-9416460692762
197361amlodipine 5 MG Oral TabletSCD186b6149-9610-4380-9bf2-9416460692762
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY186b6149-9610-4380-9bf2-9416460692762

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-691-157161006911515 TABLET in 1 BOTTLE (71610-691-15) 15 tablet2023-03-07NoNoHistorical
71610-691-307161006913030 TABLET in 1 BOTTLE (71610-691-30) 30 tablet2023-03-07NoNoHistorical
71610-691-457161006914545 TABLET in 1 BOTTLE (71610-691-45) 45 tablet2023-03-07NoNoHistorical
71610-691-607161006916090 TABLET in 1 BOTTLE (71610-691-60) 90 tablet2023-05-04NoNoHistorical