FDA.reportPublic FDA data

Norvasc

Product NDC
21695-151
11-digit product format
216950151
Labeler code
21695
Product ID
21695-151_b00570ff-4081-4514-b45b-eb6f753450f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine besylate
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA019787
Marketing category
NDA
Marketing start
1992-07-31
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE
Active strength
5 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-151-152019-09-24C16284748780-1934fe258-4779-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use NORVASC safely and effectively. See full prescribing information for NORVASC. NORVASC ® (amlodipine besylate) Tablets for oral administration Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-151-15Norvasc15 in 1 BOTTLETABLET151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-151-15EA - Each21695-15192cdc86c-83f1-4e61-944f-70612e605f5612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
amlodipine besylateACTIVE INGREDIENT864V2Q084HNORVASC (AMLODIPINE BESYLATE) TABLET [REBEL DISTRIBUTORS CORP]1
AmlodipineACTIVE MOIETY1J444QC288NORVASC (AMLODIPINE BESYLATE) TABLET [REBEL DISTRIBUTORS CORP]1
anhydrous dibasic calcium phosphateINACTIVE INGREDIENTL11K75P92JNORVASC (AMLODIPINE BESYLATE) TABLET [REBEL DISTRIBUTORS CORP]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UNORVASC (AMLODIPINE BESYLATE) TABLET [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30NORVASC (AMLODIPINE BESYLATE) TABLET [REBEL DISTRIBUTORS CORP]1
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2NORVASC (AMLODIPINE BESYLATE) TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-151NORVASC (AMLODIPINE BESYLATE) TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110414_b00570ff-4081-4514-b45b-eb6f753450f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197361amLODIPine besylate 5 MG Oral TabletPSNb00570ff-4081-4514-b45b-eb6f753450f51
212549Norvasc 5 MG Oral TabletPSNb00570ff-4081-4514-b45b-eb6f753450f51
212549amlodipine 5 MG Oral Tablet [Norvasc]SBDb00570ff-4081-4514-b45b-eb6f753450f51
197361amlodipine 5 MG Oral TabletSCDb00570ff-4081-4514-b45b-eb6f753450f51
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYb00570ff-4081-4514-b45b-eb6f753450f51
212549Norvasc (as amlodipine besylate) 5 MG Oral TabletSYb00570ff-4081-4514-b45b-eb6f753450f51
212549Norvasc 5 MG Oral TabletSYb00570ff-4081-4514-b45b-eb6f753450f51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-151-152169501511515 in 1 BOTTLEHistorical