Bisoprolol Fumarate

Product NDC
52817-268
11-digit product format
528170268
Labeler code
52817
Product ID
52817-268_32f899b9-1d84-7c3d-e063-6394a90a502c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bisoprolol Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TruPharma LLC
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
Rxcui865155

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
52817-268-30Bisoprolol Fumarate30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-268-30EA - Each52817-2689336a826-fa9c-45fc-b880-c107c130b11e12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-268BISOPROLOL FUMARATE TABLET, FILM COATED [TRUPHARMA LLC]1Current NDC, 1 package rows20250418_0ef9e45c-21ee-4e00-a9b8-280e2035b4d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
865155bisoprolol fumarate 2.5 MG Oral TabletPSN0ef9e45c-21ee-4e00-a9b8-280e2035b4d31
865155bisoprolol fumarate 2.5 MG Oral TabletSCD0ef9e45c-21ee-4e00-a9b8-280e2035b4d31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
52817-268-305281702683030 TABLET, FILM COATED in 1 BOTTLE (52817-268-30) 2025-03-07NoNoCurrent