FDA.reportPublic FDA data

Bisoprolol Fumarate

Product NDC
71335-2178
11-digit product format
713352178
Labeler code
71335
Product ID
71335-2178_93041a9f-53d9-47b4-96d7-d2b138ea1b06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bisoprolol Fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215563
Marketing category
ANDA
Marketing start
2021-10-29
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 Fumarate
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
71335-2178-1Bisoprolol Fumarate30 in 1 BOTTLETABLET30102
71335-2178-2Bisoprolol Fumarate100 in 1 BOTTLETABLET100102
71335-2178-3Bisoprolol Fumarate90 in 1 BOTTLETABLET90102
71335-2178-4Bisoprolol Fumarate28 in 1 BOTTLETABLET28102
71335-2178-5Bisoprolol Fumarate120 in 1 BOTTLETABLET120102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2178BISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 5 package rows20231118_f6ce8f14-43fc-4c5e-8378-62ca7121e918.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854905bisoprolol fumarate 5 MG Oral TabletPSNf6ce8f14-43fc-4c5e-8378-62ca7121e918102
854905bisoprolol fumarate 5 MG Oral TabletSCDf6ce8f14-43fc-4c5e-8378-62ca7121e918102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2178-17133521780130 TABLET in 1 BOTTLE (71335-2178-1) 30 tablet2022-10-170000-00-00NoNoCurrent
71335-2178-271335217802100 TABLET in 1 BOTTLE (71335-2178-2) 100 tablet2022-10-170000-00-00NoNoCurrent
71335-2178-37133521780390 TABLET in 1 BOTTLE (71335-2178-3) 90 tablet2022-10-170000-00-00NoNoCurrent
71335-2178-47133521780428 TABLET in 1 BOTTLE (71335-2178-4) 28 tablet2022-10-170000-00-00NoNoCurrent
71335-2178-571335217805120 TABLET in 1 BOTTLE (71335-2178-5) 120 tablet2022-10-170000-00-00NoNoCurrent