Bisoprolol Fumarate and Hydrochlorothiazide

Product NDC
50090-7357
11-digit product format
500907357
Labeler code
50090
Product ID
50090-7357_3848a437-d146-4818-8dec-6b1cdea5e9d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bisoprolol Fumarate and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA215995
Marketing category
ANDA
Marketing start
2022-01-26
Substance
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Active strength
5; 6.25 mg/1; mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], 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
0J48LPH2THHYDROCHLOROTHIAZIDE58-93-5HYDROCHLOROTHIAZIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7357-05009073570030 TABLET, FILM COATED in 1 BOTTLE (50090-7357-0) 2024-10-17NoNoHistorical
50090-7357-25009073570290 TABLET, FILM COATED in 1 BOTTLE (50090-7357-2) 2024-10-17NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USPA-S Medication Solutions2026-03-03HUMAN PRESCRIPTION DRUG LABEL6