FDA.reportPublic FDA data

Bisoprolol Fumarate

Product NDC
70954-456
11-digit product format
709540456
Labeler code
70954
Product ID
70954-456_6517d564-ea55-4084-a8ab-34fea548c24e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bisoprolol Fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Novitium Pharma LLC
Application
ANDA215563
Marketing category
ANDA
Marketing start
2021-10-29
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
70954-456-10Bisoprolol Fumarate30 in 1 BOTTLETABLET301
70954-456-20Bisoprolol Fumarate100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-456-10EA - Each70954-45602c24293-f8a1-45bf-a364-9d5f29ad1ac112022-01-06
70954-456-20EA - Each70954-456a9ba38c5-a955-4c83-9b4c-e6764790777312022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-456BISOPROLOL FUMARATE TABLET [NOVITIUM PHARMA LLC]1Current NDC, Legacy NDC, 2 package rows20211106_6517d564-ea55-4084-a8ab-34fea548c24e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854901bisoprolol fumarate 10 MG Oral TabletPSNdf37d337-9978-0c31-e053-2a95a90a32582
854905bisoprolol fumarate 5 MG Oral TabletPSNdf37d337-9978-0c31-e053-2a95a90a32582
854901bisoprolol fumarate 10 MG Oral TabletSCDdf37d337-9978-0c31-e053-2a95a90a32582
854905bisoprolol fumarate 5 MG Oral TabletSCDdf37d337-9978-0c31-e053-2a95a90a32582
854901bisoprolol fumarate 10 MG Oral TabletPSN6517d564-ea55-4084-a8ab-34fea548c24e1
854905bisoprolol fumarate 5 MG Oral TabletPSN6517d564-ea55-4084-a8ab-34fea548c24e1
854901bisoprolol fumarate 10 MG Oral TabletSCD6517d564-ea55-4084-a8ab-34fea548c24e1
854905bisoprolol fumarate 5 MG Oral TabletSCD6517d564-ea55-4084-a8ab-34fea548c24e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-456-107095404561030 TABLET in 1 BOTTLE (70954-456-10) 30 tablet2021-10-290000-00-00NoNoCurrent
70954-456-2070954045620100 TABLET in 1 BOTTLE (70954-456-20) 100 tablet2021-10-290000-00-00NoNoCurrent