FDA.reportPublic FDA data

Bystolic

Product NDC
68151-5135
11-digit product format
681515135
Labeler code
68151
Product ID
68151-5135_ca39c719-336a-437e-b7d2-98bb32ecd619
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nebivolol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Carilion Materials Management
Application
NDA021742
Marketing category
NDA
Marketing start
2008-01-22
Marketing end
0000-00-00
Substance
NEBIVOLOL HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b9af42fa-00cc-b314-02ce-e06da0a12313Product name620250423
52311e76-a520-4bd2-9d5b-e0b6d6f44519Product name220231208

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-5135-72020-01-31C16284748780-19d75b9d0-ad44-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use BYSTOLIC safely and effectively. See full prescribing information for BYSTOLIC. BYSTOLIC (nebivolol) tablets, for oral use Initial U.S. Approval: 2007 ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-5135-7Bystolic1 in 1 CUPTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-5135BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20151229_07ed02ff-523f-437e-bddc-5c41a4bb0062.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751616Bystolic 10 MG Oral TabletPSN07ed02ff-523f-437e-bddc-5c41a4bb00622
751612nebivolol 10 MG Oral TabletPSN07ed02ff-523f-437e-bddc-5c41a4bb00622
751616nebivolol 10 MG Oral Tablet [Bystolic]SBD07ed02ff-523f-437e-bddc-5c41a4bb00622
751612nebivolol 10 MG Oral TabletSCD07ed02ff-523f-437e-bddc-5c41a4bb00622
751616Bystolic (as nebivolol HCl) 10 MG Oral TabletSY07ed02ff-523f-437e-bddc-5c41a4bb00622
751616Bystolic 10 MG Oral TabletSY07ed02ff-523f-437e-bddc-5c41a4bb00622
751612nebivolol (as nebivolol hydrochloride) 10 MG Oral TabletSY07ed02ff-523f-437e-bddc-5c41a4bb00622

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-5135-7681515135071 in 1 CUPHistorical