Bisoprolol Fumarate

Product NDC
72888-233
11-digit product format
728880233
Labeler code
72888
Product ID
72888-233_43603823-594f-cbe7-e063-6294a90a9153
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bisoprolol Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advagen Pharma Ltd
Application
ANDA075643
Marketing category
ANDA
Marketing start
2025-03-07
Substance
BISOPROLOL FUMARATE
Active strength
2.5 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 FUMARATE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUR59KN573L
Rxcui854901, 854905, 865155

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
72888-233-01Bisoprolol Fumarate30 in 1 BOTTLETABLET, FILM COATED303

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854901bisoprolol fumarate 10 MG Oral TabletPSN83e4b4e5-9130-44c8-abab-fcd0db5d8c493
865155bisoprolol fumarate 2.5 MG Oral TabletPSN83e4b4e5-9130-44c8-abab-fcd0db5d8c493
854905bisoprolol fumarate 5 MG Oral TabletPSN83e4b4e5-9130-44c8-abab-fcd0db5d8c493
854901bisoprolol fumarate 10 MG Oral TabletSCD83e4b4e5-9130-44c8-abab-fcd0db5d8c493
865155bisoprolol fumarate 2.5 MG Oral TabletSCD83e4b4e5-9130-44c8-abab-fcd0db5d8c493
854905bisoprolol fumarate 5 MG Oral TabletSCD83e4b4e5-9130-44c8-abab-fcd0db5d8c493

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72888-233-017288802330130 TABLET, FILM COATED in 1 BOTTLE (72888-233-01) 2025-03-07NoNoCurrent