FDA.reportPublic FDA data

AMLODIPINE BESYLATE

Product NDC
71610-620
11-digit product format
716100620
Labeler code
71610
Product ID
71610-620_1490fc40-2c20-dd29-e063-6294a90aed09
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
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
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 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
71610-620-30AMLODIPINE BESYLATE30 in 1 BOTTLETABLET302
71610-620-35AMLODIPINE BESYLATE35 in 1 BOTTLETABLET352
71610-620-45AMLODIPINE BESYLATE45 in 1 BOTTLETABLET452
71610-620-60AMLODIPINE BESYLATE90 in 1 BOTTLETABLET902
71610-620-80AMLODIPINE BESYLATE180 in 1 BOTTLETABLET1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-620-30EA - Each71610-62050b54853-f3b4-45fb-90a6-b4a433b26d6212022-02-07
71610-620-35EA - Each71610-62008c5f17a-abd7-4dcc-8e1e-ff25b8f7d92a12022-02-07
71610-620-45EA - Each71610-620a2458053-6959-4fe4-a682-2964808da50112022-02-07
71610-620-60EA - Each71610-6202290316d-f071-4fcd-9c30-2c4ad1c96f3512022-02-07
71610-620-80EA - Each71610-6209c80cf9c-7562-4902-a69d-0166a155729212022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-620AMLODIPINE BESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 5 package rows20240328_d17ef907-7719-4246-8ade-b67afdfaf787.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSNd17ef907-7719-4246-8ade-b67afdfaf7872
308135amlodipine 10 MG Oral TabletSCDd17ef907-7719-4246-8ade-b67afdfaf7872
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYd17ef907-7719-4246-8ade-b67afdfaf7872

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-620-307161006203030 TABLET in 1 BOTTLE (71610-620-30) 30 tablet2021-01-100000-00-00NoNoCurrent
71610-620-357161006203535 TABLET in 1 BOTTLE (71610-620-35) 35 tablet2021-01-100000-00-00NoNoCurrent
71610-620-457161006204545 TABLET in 1 BOTTLE (71610-620-45) 45 tablet2022-01-180000-00-00NoNoCurrent
71610-620-607161006206090 TABLET in 1 BOTTLE (71610-620-60) 90 tablet2021-12-020000-00-00NoNoCurrent
71610-620-8071610062080180 TABLET in 1 BOTTLE (71610-620-80) 180 tablet2021-12-020000-00-00NoNoCurrent