FDA.reportPublic FDA data

NDC 0591-0841-01 - Bisoprolol Fumarate Hydrochlorothiazide

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0591-0841
Requested NDC
0591-0841-01
Package NDCs from labels
0591-0841-01, 0591-0841-05
Manufacturer
Watson Laboratories, Inc.
Effective date
2006-11-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bisoprolol Fumarate and Hydrochlorothiazide Tablets Revised: July 2003 Rx onlyWatson Laboratories, Inc.2006-11-27HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-0841-01Bisoprolol Fumarate Hydrochlorothiazide100 in 1 BOTTLETABLET, FILM COATED1002
0591-0841-05Bisoprolol Fumarate Hydrochlorothiazide500 in 1 BOTTLETABLET, FILM COATED5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-0841BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]22 package rows20070105_A9630311-A5DB-4FBA-B95E-5E13AD286BC8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bisoprolol FumarateACTIVE INGREDIENTUR59KN573LBISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]2
HydrochlorothiazideACTIVE INGREDIENT0J48LPH2THBISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]2
BisoprololACTIVE MOIETYY41JS2NL6UBISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]2
HydrochlorothiazideACTIVE MOIETY0J48LPH2THBISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]2
Collodial silicon dioxideINACTIVE INGREDIENTBISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]2
Dibasic calcium phosphateINACTIVE INGREDIENTBISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]2
HypromelloseINACTIVE INGREDIENTBISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]2
Lactose monohydrateINACTIVE INGREDIENTBISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]2
Magnesium stearateINACTIVE INGREDIENT70097M6I30BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]2
Microcrystalline celluloseINACTIVE INGREDIENTBISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]2
PolydextroseINACTIVE INGREDIENTBISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]2
Polyethylene glycolINACTIVE INGREDIENTBISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]2
Pregelatinized starchINACTIVE INGREDIENTBISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]2
Purified stearic acidINACTIVE INGREDIENTBISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]2
Synthetic red oxideINACTIVE INGREDIENTBISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]2
Synthetic yellow oxideINACTIVE INGREDIENTBISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]2
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPBISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]2
TriacetinINACTIVE INGREDIENTXHX3C3X673BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [WATSON LABORATORIES, INC.]2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEEdenbridge Pharmaceuticals LLC.295532b5-65c8-40c3-8d27-cfd334d128022026-08-28Warnings, Adverse reactionsExact identifier
rxcui: 854908
rxcui: 854919
rxcui: 854916
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack53221419-204c-40a2-9ec3-8e4b994dd39d2026-08-20Warnings, Adverse reactionsExact identifier
rxcui: 854916
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEA-S Medication Solutions12ba7eba-1874-41b6-aff5-7baba8b999842026-08-20Warnings, Adverse reactionsExact identifier
rxcui: 854919
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack154cb1d2-9fb2-4c8d-90de-6a8062a8d1ba2026-08-19Warnings, Adverse reactionsExact identifier
rxcui: 854919
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEANI Pharmaceuticals, Inc.a26bcf78-6515-4e9f-b2dc-4aaa8ec1a82c2026-08-12Warnings, Adverse reactionsExact identifier
rxcui: 854908
rxcui: 854919
rxcui: 854916
bisoprolol fumarate and hydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDETeva Pharmaceuticals USA, Inc.27d52b23-e3e2-4339-b00e-cd0fec43ffbb2026-08-11Warnings, Adverse reactionsExact identifier
rxcui: 854908
rxcui: 854919
rxcui: 854916
bisoprolol fumarate and hydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEUnichem Pharmaceuticals (USA), Inc.b9ee689a-ea12-435d-b01c-70d45891e62f2026-08-06Warnings, Adverse reactionsExact identifier
rxcui: 854908
rxcui: 854919
rxcui: 854916
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEViona Pharmaceuticals Inc57505d73-f2a8-430b-8703-a0a6bb733c7d2026-07-31Warnings, Adverse reactionsExact identifier
rxcui: 854908
rxcui: 854919
rxcui: 854916
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEMylan Pharmaceuticals Inc.d4243a76-516c-417e-80ba-444a21ecc6882026-05-12Warnings, Adverse reactionsExact identifier
rxcui: 854908
rxcui: 854919
rxcui: 854916
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEA-S Medication Solutions9271a2d7-be94-4e38-9f71-41e8d55e10bc2026-03-03Warnings, Adverse reactionsExact identifier
rxcui: 854919
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEA-S Medication Solutions90bb2207-2eaf-495b-a222-c69d4db9e7a32026-01-14Warnings, Adverse reactionsExact identifier
rxcui: 854919
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEMarlex Pharmaceuticals, Inc.df881501-42ae-624a-e053-2995a90ab2a02025-09-23Warnings, Adverse reactionsExact identifier
rxcui: 854908
rxcui: 854919
rxcui: 854916
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEA-S Medication Solutions6b7f96c3-daf4-4029-a96b-baa37add0edb2025-09-05Warnings, Adverse reactionsExact identifier
rxcui: 854908
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack794d4a5a-de31-4878-95d5-23552dd2171e2025-06-04Warnings, Adverse reactionsExact identifier
rxcui: 854919
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack8d3e9c30-8dcf-491a-a515-6890b391398e2025-05-29Warnings, Adverse reactionsExact identifier
rxcui: 854916
bisoprolol fumarate and hydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack447c11b6-72fe-418e-a2db-5d90b53477962024-05-23Warnings, Adverse reactionsExact identifier
rxcui: 854919
bisoprolol fumarate and hydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack36fbc5fc-4a75-4aa3-bed1-78944135ae112024-05-17Warnings, Adverse reactionsExact identifier
rxcui: 854916
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEA-S Medication Solutions78df389a-0916-46db-a536-72cae9ad6c082024-01-02Warnings, Adverse reactionsExact identifier
rxcui: 854908
bisoprolol fumarate and hydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEA-S Medication Solutionscf088009-203e-4d70-b56e-b4062cf3fcd82023-05-19Warnings, Adverse reactionsExact identifier
rxcui: 854916
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEZydus Lifesciences Limited35ed3030-a9b3-4e4e-99cd-6d5c31ad22fa2022-11-07Exact identifier
rxcui: 854908
rxcui: 854919
rxcui: 854916

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.