Bisoprolol Fumarate

Product NDC
70771-1727
11-digit product format
707711727
Labeler code
70771
Product ID
70771-1727_bd36cf67-11ab-4a1f-b1b6-9d5c078a9206
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bisoprolol Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA215680
Marketing category
ANDA
Marketing start
2022-09-15
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
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1727-1Bisoprolol Fumarate100 in 1 BOTTLETABLET, FILM COATED1002
70771-1727-3Bisoprolol Fumarate30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1727BISOPROLOL FUMARATE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]2Current NDC, Legacy NDC, 2 package rows20240817_2d380e61-052c-4c33-8a35-01c9eb651d68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854901bisoprolol fumarate 10 MG Oral TabletPSN2d380e61-052c-4c33-8a35-01c9eb651d682
854905bisoprolol fumarate 5 MG Oral TabletPSN2d380e61-052c-4c33-8a35-01c9eb651d682
854901bisoprolol fumarate 10 MG Oral TabletSCD2d380e61-052c-4c33-8a35-01c9eb651d682
854905bisoprolol fumarate 5 MG Oral TabletSCD2d380e61-052c-4c33-8a35-01c9eb651d682

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70771-1727-170771172701100 TABLET, FILM COATED in 1 BOTTLE (70771-1727-1) 2022-09-150000-00-00NoNoCurrent
70771-1727-37077117270330 TABLET, FILM COATED in 1 BOTTLE (70771-1727-3) 2022-09-150000-00-00NoNoCurrent