Bisoprolol Fumarate

Product NDC
72578-112
11-digit product format
725780112
Labeler code
72578
Product ID
72578-112_d47ca4c0-7783-43d1-a951-5adca27ea13c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bisoprolol Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA215680
Marketing category
ANDA
Marketing start
2022-09-15
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
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 FUMARATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUR59KN573L
Rxcui854901, 854905

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
72578-112-01Bisoprolol Fumarate100 in 1 BOTTLETABLET, FILM COATED1002
72578-112-06Bisoprolol Fumarate30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-112-01EA - Each72578-112d1c38987-c6f5-4e6a-bc55-b541e136c0f512023-03-13
72578-112-06EA - Each72578-1129c39515c-be3f-426d-abe8-c4fc582fe8e312023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-112BISOPROLOL FUMARATE TABLET, FILM COATED [VIONA PHARMACEUTICALS INC]2Current NDC, Legacy NDC, 2 package rows20231111_3c393b41-9423-4ea6-8a79-0cbff0693471.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854901bisoprolol fumarate 10 MG Oral TabletPSN3c393b41-9423-4ea6-8a79-0cbff06934712
854905bisoprolol fumarate 5 MG Oral TabletPSN3c393b41-9423-4ea6-8a79-0cbff06934712
854901bisoprolol fumarate 10 MG Oral TabletSCD3c393b41-9423-4ea6-8a79-0cbff06934712
854905bisoprolol fumarate 5 MG Oral TabletSCD3c393b41-9423-4ea6-8a79-0cbff06934712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72578-112-0172578011201100 TABLET, FILM COATED in 1 BOTTLE (72578-112-01) 2022-09-150000-00-00NoNoCurrent
72578-112-067257801120630 TABLET, FILM COATED in 1 BOTTLE (72578-112-06) 2022-09-150000-00-00NoNoCurrent