Bisoprolol Fumarate and Hydrochlorothiazide

Product NDC
70518-3530
11-digit product format
705183530
Labeler code
70518
Product ID
70518-3530_e9335d05-5c99-0e3f-e053-2995a90a59d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bisoprolol Fumarate and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA212678
Marketing category
ANDA
Marketing start
2022-09-20
Marketing end
0000-00-00
Substance
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Active strength
10 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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3530-07051835300090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3530-0) 2022-09-200000-00-00NoNoCurrent