FDA.reportPublic FDA data

Bisoprolol Fumarate

Product NDC
51407-645
11-digit product format
514070645
Labeler code
51407
Product ID
51407-645_4ffb30c3-c812-9e7e-e063-6294a90a24b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bisoprolol Fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA215563
Marketing category
ANDA
Marketing start
2021-10-29
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bisoprolol Fumarate
Listing expiration
2027-12-31

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
51407-645-01Bisoprolol Fumarate100 in 1 BOTTLETABLET1002
51407-645-30Bisoprolol Fumarate30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-645-01EA - Each51407-645412770c2-d6d1-457b-89dd-760376909f1212022-06-06
51407-645-30EA - Each51407-645488fa69f-7263-47b7-be6c-611b6f642aaa12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-645BISOPROLOL FUMARATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1Current NDC, Legacy NDC, 2 package rows20220519_df37d337-9978-0c31-e053-2a95a90a3258.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-645-0151407064501100 TABLET in 1 BOTTLE (51407-645-01) 100 tablet2022-03-230000-00-00NoNoCurrent
51407-645-305140706453030 TABLET in 1 BOTTLE (51407-645-30) 30 tablet2022-03-230000-00-00NoNoCurrent