FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
71335-1865
11-digit product format
713351865
Labeler code
71335
Product ID
71335-1865_ef2eb5d8-d32f-4b45-af1d-5efd4b9ebfb2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203245
Marketing category
ANDA
Marketing start
2019-05-22
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
71335-1865-0Amlodipine Besylate7 in 1 BOTTLE, PLASTICTABLET7104
71335-1865-1Amlodipine Besylate30 in 1 BOTTLE, PLASTICTABLET30104
71335-1865-2Amlodipine Besylate90 in 1 BOTTLE, PLASTICTABLET90104
71335-1865-3Amlodipine Besylate60 in 1 BOTTLE, PLASTICTABLET60104
71335-1865-4Amlodipine Besylate120 in 1 BOTTLE, PLASTICTABLET120104
71335-1865-5Amlodipine Besylate100 in 1 BOTTLE, PLASTICTABLET100104
71335-1865-6Amlodipine Besylate800 in 1 BOTTLE, PLASTICTABLET800104
71335-1865-7Amlodipine Besylate1000 in 1 BOTTLE, PLASTICTABLET1000104
71335-1865-8Amlodipine Besylate180 in 1 BOTTLE, PLASTICTABLET180104
71335-1865-9Amlodipine Besylate10 in 1 BOTTLETABLET10104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1865-1EA - Each71335-18651436fa60-60d3-4274-87ee-4838e5a9ba9412026-01-08
71335-1865-2EA - Each71335-1865a1681432-523e-4486-8a72-2d15a9c4e84012025-08-11
71335-1865-5EA - Each71335-1865f9628de3-e748-4f38-8133-73918d353d7312026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1865AMLODIPINE BESYLATE TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 10 package rows20240823_b1151904-5085-49bd-94ec-cb2894f4eb10.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSNb1151904-5085-49bd-94ec-cb2894f4eb10104
308135amlodipine 10 MG Oral TabletSCDb1151904-5085-49bd-94ec-cb2894f4eb10104
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYb1151904-5085-49bd-94ec-cb2894f4eb10104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1865-0713351865007 TABLET in 1 BOTTLE, PLASTIC (71335-1865-0) 7 tablet2024-05-22NoNoHistorical
71335-1865-17133518650130 TABLET in 1 BOTTLE, PLASTIC (71335-1865-1) 30 tablet2024-05-220000-00-00NoNoCurrent
71335-1865-27133518650290 TABLET in 1 BOTTLE, PLASTIC (71335-1865-2) 90 tablet2024-05-220000-00-00NoNoCurrent
71335-1865-37133518650360 TABLET in 1 BOTTLE, PLASTIC (71335-1865-3) 60 tablet2024-05-220000-00-00NoNoCurrent
71335-1865-471335186504120 TABLET in 1 BOTTLE, PLASTIC (71335-1865-4) 120 tablet2024-05-220000-00-00NoNoCurrent
71335-1865-571335186505100 TABLET in 1 BOTTLE, PLASTIC (71335-1865-5) 100 tablet2024-05-220000-00-00NoNoCurrent
71335-1865-671335186506800 TABLET in 1 BOTTLE, PLASTIC (71335-1865-6) 800 tablet2024-05-220000-00-00NoNoCurrent
71335-1865-7713351865071000 TABLET in 1 BOTTLE, PLASTIC (71335-1865-7) 1000 tablet2024-05-220000-00-00NoNoCurrent
71335-1865-871335186508180 TABLET in 1 BOTTLE, PLASTIC (71335-1865-8) 180 tablet2024-05-220000-00-00NoNoCurrent
71335-1865-97133518650910 TABLET in 1 BOTTLE (71335-1865-9) 10 tablet2024-05-22NoNoHistorical