Bisoprolol Fumarate

Product NDC
68788-8671
11-digit product format
687888671
Labeler code
68788
Product ID
68788-8671_56ee5e1d-4ca1-44de-be60-34563e10c2a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bisoprolol fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078635
Marketing category
ANDA
Marketing start
2024-05-21
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
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
68788-8671-1Bisoprolol Fumarate100 in 1 BOTTLE, PLASTICTABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8671-1EA - Each68788-86711acd384e-e351-4d2b-9999-9000092b509312024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8671BISOPROLOL FUMARATE TABLET [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 1 package rows20250210_c0e309f3-82c3-4629-b790-fb8538b87369.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854905bisoprolol fumarate 5 MG Oral TabletPSNc0e309f3-82c3-4629-b790-fb8538b873693
854905bisoprolol fumarate 5 MG Oral TabletSCDc0e309f3-82c3-4629-b790-fb8538b873693

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8671-168788867101100 TABLET in 1 BOTTLE, PLASTIC (68788-8671-1) 100 tablet2024-05-21NoNoCurrent