FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
42291-027
11-digit product format
422910027
Labeler code
42291
Product ID
42291-027_48481e73-92af-d506-e063-6394a90a6518
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA076846
Marketing category
ANDA
Marketing start
2023-06-22
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amlodipine Besylate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii864V2Q084H
Rxcui197361, 308135, 308136

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
42291-027-10Amlodipine Besylate1000 in 1 BOTTLETABLET10002
42291-027-90Amlodipine Besylate90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-027AMLODIPINE BESYLATE TABLET [AVKARE]1Current NDC, 2 package rows20230623_feb9438a-9cbc-4855-e053-6394a90af15e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSNfeb9438a-9cbc-4855-e053-6394a90af15e2
308136amLODIPine besylate 2.5 MG Oral TabletPSNfeb9438a-9cbc-4855-e053-6394a90af15e2
197361amLODIPine besylate 5 MG Oral TabletPSNfeb9438a-9cbc-4855-e053-6394a90af15e2
308135amlodipine 10 MG Oral TabletSCDfeb9438a-9cbc-4855-e053-6394a90af15e2
308136amlodipine 2.5 MG Oral TabletSCDfeb9438a-9cbc-4855-e053-6394a90af15e2
197361amlodipine 5 MG Oral TabletSCDfeb9438a-9cbc-4855-e053-6394a90af15e2
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYfeb9438a-9cbc-4855-e053-6394a90af15e2
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSYfeb9438a-9cbc-4855-e053-6394a90af15e2
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYfeb9438a-9cbc-4855-e053-6394a90af15e2
308135amLODIPine besylate 10 MG Oral TabletPSN3ce6978a-6ab3-33a9-e063-6294a90a24a11
308135amlodipine 10 MG Oral TabletSCD3ce6978a-6ab3-33a9-e063-6294a90a24a11
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY3ce6978a-6ab3-33a9-e063-6294a90a24a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42291-027-10422910027101000 TABLET in 1 BOTTLE (42291-027-10) 1000 tablet2023-06-22NoNoCurrent
42291-027-904229100279090 TABLET in 1 BOTTLE (42291-027-90) 90 tablet2023-06-22NoNoCurrent