Bisoprolol Fumarate

Product NDC
0378-0523
11-digit product format
003780523
Labeler code
0378
Product ID
0378-0523_df710284-e519-4d94-aaca-476d3745f7fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bisoprolol fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA075831
Marketing category
ANDA
Marketing start
2012-09-24
Marketing end
2020-11-30
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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0523-01EA - Each0378-05234cc7a30f-8325-4859-8407-3b3c1253f4a012012-07-24
0378-0523-93EA - Each0378-0523247858a3-30f9-4196-ac49-596d3b6bebd312012-07-24