FDA.reportPublic FDA data

Bisoprolol Fumarate

Product NDC
63187-871
11-digit product format
631870871
Labeler code
63187
Product ID
63187-871_ea42fd4b-fc18-451c-9550-706abfbe7513
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bisoprolol fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078635
Marketing category
ANDA
Marketing start
2009-09-21
Substance
BISOPROLOL FUMARATE
Active strength
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 FUMARATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUR59KN573L
Rxcui854905

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
63187-871-30Bisoprolol Fumarate30 in 1 BOTTLE, PLASTICTABLET302
63187-871-60Bisoprolol Fumarate60 in 1 BOTTLE, PLASTICTABLET602
63187-871-90Bisoprolol Fumarate90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-871-90EA - Each63187-8717170ecb3-a4c9-4737-b77c-4ae587f9153d12017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-871BISOPROLOL FUMARATE TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20191113_bce7e65a-148f-4ccd-9305-bc7331dbcca4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854905bisoprolol fumarate 5 MG Oral TabletPSNbce7e65a-148f-4ccd-9305-bc7331dbcca42
854905bisoprolol fumarate 5 MG Oral TabletSCDbce7e65a-148f-4ccd-9305-bc7331dbcca42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-871-306318708713030 TABLET in 1 BOTTLE, PLASTIC (63187-871-30) 30 tablet2017-07-030000-00-00NoNoCurrent
63187-871-606318708716060 TABLET in 1 BOTTLE, PLASTIC (63187-871-60) 60 tablet2017-07-030000-00-00NoNoCurrent
63187-871-906318708719090 TABLET in 1 BOTTLE, PLASTIC (63187-871-90) 90 tablet2017-07-030000-00-00NoNoCurrent