BISOPROLOL FUMARATE

Product NDC
15955-374
11-digit product format
159550374
Labeler code
15955
Product ID
15955-374_b6340ba8-e8d5-4d13-bcfa-d1a0cea085d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BISOPROLOL FUMARATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Labs LLC
Application
ANDA204891
Marketing category
ANDA
Marketing start
2019-09-11
Marketing end
0000-00-00
Substance
BISOPROLOL FUMARATE
Active strength
10 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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
15955-374-302022-01-28C16284748780-1d6a99b39-99d2-a426-e053-dadaa90af4c2BISOPROLOL FUMARATE Tablets, USP Rx only
15955-374-502022-01-28C16284748780-1d6a99b39-99d2-a426-e053-dadaa90af4c2BISOPROLOL FUMARATE Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15955-374-30BISOPROLOL FUMARATE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302
15955-374-50BISOPROLOL FUMARATE500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15955-374BISOPROLOL FUMARATE TABLET, FILM COATED [ALEMBIC LABS LLC]2Legacy NDC, 2 package rows20201127_230b6ffb-0586-4e80-962c-80058c1a14bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854901bisoprolol fumarate 10 MG Oral TabletPSN230b6ffb-0586-4e80-962c-80058c1a14bd2
854905bisoprolol fumarate 5 MG Oral TabletPSN230b6ffb-0586-4e80-962c-80058c1a14bd2
854901bisoprolol fumarate 10 MG Oral TabletSCD230b6ffb-0586-4e80-962c-80058c1a14bd2
854905bisoprolol fumarate 5 MG Oral TabletSCD230b6ffb-0586-4e80-962c-80058c1a14bd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
15955-374-301595503743030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (15955-374-30) 2019-09-110000-00-00NoNoCurrent
15955-374-5015955037450500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (15955-374-50) 2019-09-110000-00-00NoNoCurrent