Bisoprolol Fumarate and Hydrochlorothiazide

Product NDC
70518-3207
11-digit product format
705183207
Labeler code
70518
Product ID
70518-3207_cac91cda-a28f-0e2b-e053-2995a90aee48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bisoprolol fumarate and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA075768
Marketing category
ANDA
Marketing start
2021-08-30
Marketing end
0000-00-00
Substance
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Active strength
10 mg/1; mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3207-02023-03-21C16284748780-1f386c649-d922-0266-e053-dadaa90a7c1ab9cbc447-796d-4e9d-bcb1-d9b6527450d3
70518-3207-02023-01-30C16284748780-1f386c649-d922-0266-e053-dadaa90a7c1ab9cbc447-796d-4e9d-bcb1-d9b6527450d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3207-07051832070090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3207-0) 2021-08-300000-00-00NoNoCurrent