FDA.reportPublic FDA data

AMLODIPINE BESYLATE

Product NDC
71610-687
11-digit product format
716100687
Labeler code
71610
Product ID
71610-687_a4b2d571-c110-49fb-8eff-688308608ae3
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
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
Brand name suffix
5 mg
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
71610-687-15AMLODIPINE BESYLATE5 mg15 in 1 BOTTLE, PLASTICTABLET152
71610-687-30AMLODIPINE BESYLATE5 mg30 in 1 BOTTLE, PLASTICTABLET302
71610-687-45AMLODIPINE BESYLATE5 mg45 in 1 BOTTLE, PLASTICTABLET452
71610-687-60AMLODIPINE BESYLATE5 mg90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-687-15EA - Each71610-6876552d8be-95a9-4a95-aad2-e11b140c2e3312023-10-16
71610-687-30EA - Each71610-6873ed3958d-88fb-4601-adc4-fd32552bf55c12024-04-05
71610-687-45EA - Each71610-687442c7508-6648-4acd-b6e7-3bf96d0d002012024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-687AMLODIPINE BESYLATE 5 MG (AMLODIPINE BESYLATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, 4 package rows20230420_b597d1e1-aba1-4272-bed7-4c95e8150d58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197361amLODIPine besylate 5 MG Oral TabletPSNb597d1e1-aba1-4272-bed7-4c95e8150d582
197361amlodipine 5 MG Oral TabletSCDb597d1e1-aba1-4272-bed7-4c95e8150d582
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYb597d1e1-aba1-4272-bed7-4c95e8150d582

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-687-157161006871515 TABLET in 1 BOTTLE, PLASTIC (71610-687-15) 15 tablet2023-01-19NoNoHistorical
71610-687-307161006873030 TABLET in 1 BOTTLE, PLASTIC (71610-687-30) 30 tablet2023-01-19NoNoHistorical
71610-687-457161006874545 TABLET in 1 BOTTLE, PLASTIC (71610-687-45) 45 tablet2023-01-19NoNoHistorical
71610-687-607161006876090 TABLET in 1 BOTTLE, PLASTIC (71610-687-60) 90 tablet2023-04-18NoNoHistorical