Bisoprolol Fumarate

Product NDC
64980-709
11-digit product format
649800709
Labeler code
64980
Product ID
64980-709_520db5c6-f4f3-4574-a36b-5a548f61a344
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bisoprolol Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA219044
Marketing category
ANDA
Marketing start
2025-07-11
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
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
64980-709-01Bisoprolol Fumarate100 in 1 BOTTLETABLET, FILM COATED1001
64980-709-03Bisoprolol Fumarate30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-709-01EA - Each64980-709f03b45a1-2d9d-4578-b72e-c1bca1c7898512025-10-14
64980-709-03EA - Each64980-709374df012-70f2-45ff-83bf-8a93e3a76e0812025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854901bisoprolol fumarate 10 MG Oral TabletPSN200ab93b-6ad3-46cb-8f57-db056a14de161
854905bisoprolol fumarate 5 MG Oral TabletPSN200ab93b-6ad3-46cb-8f57-db056a14de161
854901bisoprolol fumarate 10 MG Oral TabletSCD200ab93b-6ad3-46cb-8f57-db056a14de161
854905bisoprolol fumarate 5 MG Oral TabletSCD200ab93b-6ad3-46cb-8f57-db056a14de161

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
64980-709-0164980070901100 TABLET, FILM COATED in 1 BOTTLE (64980-709-01) 2025-07-11NoNoCurrent
64980-709-036498007090330 TABLET, FILM COATED in 1 BOTTLE (64980-709-03) 2025-07-11NoNoCurrent