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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
UR59KN573LBISOPROLOL FUMARATE104344-23-2BISOPROLOL FUMARATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8671-168788867101100 TABLET in 1 BOTTLE, PLASTIC (68788-8671-1) 100 tablet2024-05-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Bisoprolol Fumarate Tablets USPPreferred Pharmaceuticals Inc.2026-03-20HUMAN PRESCRIPTION DRUG LABEL3