FDA.reportPublic FDA data

Bisoprolol Fumarate

Product NDC
50268-127
11-digit product format
502680127
Labeler code
50268
Product ID
50268-127_0e85a1ff-1540-187e-e063-6394a90a3b1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bisoprolol Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA077910
Marketing category
ANDA
Marketing start
2022-01-10
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
50268-127-11Bisoprolol Fumarate1 in 1 BLISTER PACKTABLET, FILM COATED12
50268-127-15Bisoprolol Fumarate50 in 1 BOXTABLET, FILM COATED502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-127-11EA - Each50268-1271cca4b2a-0880-4c97-bac3-33cf5188c7a012022-02-07
50268-127-15EA - Each50268-12776bd8366-bdc6-4185-a1b5-9ecd24042f3d12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-127BISOPROLOL FUMARATE TABLET, FILM COATED [AVPAK]2Current NDC, Legacy NDC, 2 package rows20240110_d540ef44-9016-9d66-e053-2a95a90a16a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854905bisoprolol fumarate 5 MG Oral TabletPSNd540ef44-9016-9d66-e053-2a95a90a16a92
854905bisoprolol fumarate 5 MG Oral TabletSCDd540ef44-9016-9d66-e053-2a95a90a16a92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-127-11502680127111 in 1 BLISTER PACKHistorical
50268-127-155026801271550 BLISTER PACK in 1 BOX (50268-127-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-127-11) 50 blister pack2022-01-100000-00-00NoNoCurrent