FDA.reportPublic FDA data

AMLODIPINE BESYLATE

Product NDC
71610-978
11-digit product format
716100978
Labeler code
71610
Product ID
71610-978_47e48dff-09df-2ea2-e063-6394a90a8e41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMLODIPINE BESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078414
Marketing category
ANDA
Marketing start
2021-10-01
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
Brand name suffix
10 mg
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii864V2Q084H
Rxcui308135

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-978-30AMLODIPINE BESYLATE10 mg30 in 1 BOTTLETABLET301
71610-978-45AMLODIPINE BESYLATE10 mg45 in 1 BOTTLETABLET451
71610-978-53AMLODIPINE BESYLATE10 mg60 in 1 BOTTLETABLET601
71610-978-60AMLODIPINE BESYLATE10 mg90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-978-30EA - Each71610-978d0c928b9-6f03-4a49-93ed-070ab6ff8f3812026-03-17
71610-978-45EA - Each71610-978f80ec46f-035b-4e3b-a342-7ba35890af9712026-03-17
71610-978-53EA - Each71610-9783adfc7db-8427-4aa4-8eff-c8e673752a8612026-03-17
71610-978-60EA - Each71610-9786118acd7-98ec-4466-8efc-67ef2cd5ad4d12026-03-17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-978-307161009783030 TABLET in 1 BOTTLE (71610-978-30) 30 tablet2026-01-08NoNoHistorical
71610-978-457161009784545 TABLET in 1 BOTTLE (71610-978-45) 45 tablet2026-01-08NoNoHistorical
71610-978-537161009785360 TABLET in 1 BOTTLE (71610-978-53) 60 tablet2026-01-08NoNoHistorical
71610-978-607161009786090 TABLET in 1 BOTTLE (71610-978-60) 90 tablet2026-01-08NoNoHistorical