Bisoprolol

Product NDC
52817-271
11-digit product format
528170271
Labeler code
52817
Product ID
52817-271_2a9e4180-cb1c-f924-e063-6394a90a60c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bisoprolol fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TruPharma, LLC
Application
ANDA075474
Marketing category
ANDA
Marketing start
2019-06-20
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
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
52817-271-10Bisoprolol100 in 1 BOTTLETABLET, FILM COATED1005
52817-271-30Bisoprolol30 in 1 BOTTLETABLET, FILM COATED305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-271-10EA - Each52817-271be5d76be-a7e1-4e90-a779-70c5f555765012019-08-06
52817-271-30EA - Each52817-2718ae00826-d355-44ff-b836-23338a94244e12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-271BISOPROLOL (BISOPROLOL FUMARATE) TABLET, FILM COATED [TRUPHARMA, LLC]5Current NDC, Legacy NDC, 2 package rows20250102_bba0bc2b-602f-4df1-a761-85bd3c80c7de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854901bisoprolol fumarate 10 MG Oral TabletPSN7ec24259-0f37-4389-873b-e62267a21d678
854901bisoprolol fumarate 10 MG Oral TabletSCD7ec24259-0f37-4389-873b-e62267a21d678
854901bisoprolol fumarate 10 MG Oral TabletPSNbba0bc2b-602f-4df1-a761-85bd3c80c7de5
854905bisoprolol fumarate 5 MG Oral TabletPSNbba0bc2b-602f-4df1-a761-85bd3c80c7de5
854901bisoprolol fumarate 10 MG Oral TabletSCDbba0bc2b-602f-4df1-a761-85bd3c80c7de5
854905bisoprolol fumarate 5 MG Oral TabletSCDbba0bc2b-602f-4df1-a761-85bd3c80c7de5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52817-271-1052817027110100 TABLET, FILM COATED in 1 BOTTLE (52817-271-10) 2019-06-200000-00-00NoNoCurrent
52817-271-305281702713030 TABLET, FILM COATED in 1 BOTTLE (52817-271-30) 2019-06-200000-00-00NoNoCurrent