Bisoprolol fumarate

Product NDC
43547-617
11-digit product format
435470617
Labeler code
43547
Product ID
43547-617_e8b6cea1-8a7f-4255-8a24-ff96d6ceece2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bisoprolol fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare US, LLC
Application
ANDA217368
Marketing category
ANDA
Marketing start
2022-07-05
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-617-03Bisoprolol fumarate30 in 1 BOTTLETABLET303
43547-617-10Bisoprolol fumarate100 in 1 BOTTLETABLET1003
43547-617-50Bisoprolol fumarate500 in 1 BOTTLETABLET5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-617BISOPROLOL FUMARATE TABLET [SOLCO HEALTHCARE US, LLC]3Current NDC, 3 package rows20250502_084308e4-3b8b-40d6-acbf-d775772a8a73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854901bisoprolol fumarate 10 MG Oral TabletPSN084308e4-3b8b-40d6-acbf-d775772a8a733
854905bisoprolol fumarate 5 MG Oral TabletPSN084308e4-3b8b-40d6-acbf-d775772a8a733
854901bisoprolol fumarate 10 MG Oral TabletSCD084308e4-3b8b-40d6-acbf-d775772a8a733
854905bisoprolol fumarate 5 MG Oral TabletSCD084308e4-3b8b-40d6-acbf-d775772a8a733

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43547-617-034354706170330 TABLET in 1 BOTTLE (43547-617-03) 30 tablet2022-07-05NoNoCurrent
43547-617-1043547061710100 TABLET in 1 BOTTLE (43547-617-10) 100 tablet2022-07-05NoNoCurrent
43547-617-5043547061750500 TABLET in 1 BOTTLE (43547-617-50) 500 tablet2022-07-05NoNoCurrent