BISOPROLOL FUMARATE

Product NDC
61919-787
11-digit product format
619190787
Labeler code
61919
Product ID
61919-787_849ef938-5310-a4d2-e053-2991aa0a1c70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BISOPROLOL FUMARATE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECTRX
Application
ANDA078635
Marketing category
ANDA
Marketing start
2019-03-21
Marketing end
0000-00-00
Substance
BISOPROLOL FUMARATE
Active strength
5 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
97e4a60d-917d-ef62-dc8a-bd557b62b708Product name720260129
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-787-902025-01-30C16284748780-12cef2736-8d37-d83d-e063-dadaa90ab31fBISOPROLOL FUMARATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-787-90BISOPROLOL FUMARATE90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-787-90EA - Each61919-787ef59b3e6-61e7-45b2-ab32-5de55cd5e80012019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-787BISOPROLOL FUMARATE TABLET [DIRECTRX]1Legacy NDC, 1 package rows20190328_849ef938-530f-a4d2-e053-2991aa0a1c70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854905bisoprolol fumarate 5 MG Oral TabletPSN849ef938-530f-a4d2-e053-2991aa0a1c701
854905bisoprolol fumarate 5 MG Oral TabletSCD849ef938-530f-a4d2-e053-2991aa0a1c701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-787-906191907879090 TABLET in 1 BOTTLE (61919-787-90) 90 tablet2019-03-210000-00-00NoNoCurrent