FDA.reportPublic FDA data

Norvasc

Product NDC
58151-355
11-digit product format
581510355
Labeler code
58151
Product ID
58151-355_643fa1a0-53d9-4ce8-bc04-44285b006997
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine besylate
Dosage form
TABLET
Route
ORAL
Labeler
Viatris Specialty LLC
Application
NDA019787
Marketing category
NDA
Marketing start
2024-02-09
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
Norvasc
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii864V2Q084H
Rxcui197361, 212542, 212549, 212575, 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
58151-355-77Norvasc90 in 1 BOTTLETABLET9010
58151-355-88Norvasc1 in 1 BLISTER PACKTABLET110
58151-355-88Norvasc100 in 1 BOX, UNIT-DOSETABLET10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58151-355-77EA - Each58151-355d80b38a9-d8fa-4674-b6f6-c388830e894312024-06-10
58151-355-88EA - Each58151-35593c98c6e-c422-4940-a6d9-90e2bba15e3c12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58151-355NORVASC (AMLODIPINE BESYLATE) TABLET [VIATRIS SPECIALTY LLC]8Current NDC, 3 package rows20250125_7367289c-b0b0-466a-83e2-558e2985c29f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN7367289c-b0b0-466a-83e2-558e2985c29f10
308136amLODIPine besylate 2.5 MG Oral TabletPSN7367289c-b0b0-466a-83e2-558e2985c29f10
197361amLODIPine besylate 5 MG Oral TabletPSN7367289c-b0b0-466a-83e2-558e2985c29f10
212575Norvasc 10 MG Oral TabletPSN7367289c-b0b0-466a-83e2-558e2985c29f10
212542Norvasc 2.5 MG Oral TabletPSN7367289c-b0b0-466a-83e2-558e2985c29f10
212549Norvasc 5 MG Oral TabletPSN7367289c-b0b0-466a-83e2-558e2985c29f10
212575amlodipine 10 MG Oral Tablet [Norvasc]SBD7367289c-b0b0-466a-83e2-558e2985c29f10
212542amlodipine 2.5 MG Oral Tablet [Norvasc]SBD7367289c-b0b0-466a-83e2-558e2985c29f10
212549amlodipine 5 MG Oral Tablet [Norvasc]SBD7367289c-b0b0-466a-83e2-558e2985c29f10
308135amlodipine 10 MG Oral TabletSCD7367289c-b0b0-466a-83e2-558e2985c29f10
308136amlodipine 2.5 MG Oral TabletSCD7367289c-b0b0-466a-83e2-558e2985c29f10
197361amlodipine 5 MG Oral TabletSCD7367289c-b0b0-466a-83e2-558e2985c29f10
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY7367289c-b0b0-466a-83e2-558e2985c29f10
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY7367289c-b0b0-466a-83e2-558e2985c29f10
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY7367289c-b0b0-466a-83e2-558e2985c29f10
212575Norvasc (as amlodipine besylate) 10 MG Oral TabletSY7367289c-b0b0-466a-83e2-558e2985c29f10
212542Norvasc (as amlodipine besylate) 2.5 MG Oral TabletSY7367289c-b0b0-466a-83e2-558e2985c29f10
212549Norvasc (as amlodipine besylate) 5 MG Oral TabletSY7367289c-b0b0-466a-83e2-558e2985c29f10
212575Norvasc 10 MG Oral TabletSY7367289c-b0b0-466a-83e2-558e2985c29f10
212542Norvasc 2.5 MG Oral TabletSY7367289c-b0b0-466a-83e2-558e2985c29f10
212549Norvasc 5 MG Oral TabletSY7367289c-b0b0-466a-83e2-558e2985c29f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58151-355-775815103557790 TABLET in 1 BOTTLE (58151-355-77) 90 tablet2024-05-24NoNoCurrent
58151-355-8858151035588100 BLISTER PACK in 1 BOX, UNIT-DOSE (58151-355-88) / 1 TABLET in 1 BLISTER PACK100 blister pack2024-02-09NoNoCurrent