Bisoprolol

Product NDC
71335-1678
11-digit product format
713351678
Labeler code
71335
Product ID
71335-1678_4bb725ef-4484-4f1a-a2b4-471633683660
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bisoprolol fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075474
Marketing category
ANDA
Marketing start
2019-06-20
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bisoprolol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISOPROLOL FUMARATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUR59KN573L
Rxcui854905

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1678-1Bisoprolol30 in 1 BOTTLETABLET, FILM COATED303
71335-1678-2Bisoprolol100 in 1 BOTTLETABLET, FILM COATED1003
71335-1678-3Bisoprolol90 in 1 BOTTLETABLET, FILM COATED903
71335-1678-4Bisoprolol28 in 1 BOTTLETABLET, FILM COATED283
71335-1678-5Bisoprolol120 in 1 BOTTLETABLET, FILM COATED1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1678BISOPROLOL (BISOPROLOL FUMARATE) TABLET, FILM COATED [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 5 package rows20231118_91d114ce-5551-455e-82df-d058eb222ac1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854905bisoprolol fumarate 5 MG Oral TabletPSN91d114ce-5551-455e-82df-d058eb222ac13
854905bisoprolol fumarate 5 MG Oral TabletSCD91d114ce-5551-455e-82df-d058eb222ac13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1678-17133516780130 TABLET, FILM COATED in 1 BOTTLE (71335-1678-1) 2020-07-280000-00-00NoNoCurrent
71335-1678-271335167802100 TABLET, FILM COATED in 1 BOTTLE (71335-1678-2) 2021-12-290000-00-00NoNoCurrent
71335-1678-37133516780390 TABLET, FILM COATED in 1 BOTTLE (71335-1678-3) 2021-12-290000-00-00NoNoCurrent
71335-1678-47133516780428 TABLET, FILM COATED in 1 BOTTLE (71335-1678-4) 2021-12-290000-00-00NoNoCurrent
71335-1678-571335167805120 TABLET, FILM COATED in 1 BOTTLE (71335-1678-5) 2021-12-290000-00-00NoNoCurrent