FDA.reportPublic FDA data

NDC 0378-0501-10 - Bisoprolol Fumarate and 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
0378-0501
Requested NDC
0378-0501-10
Package NDCs from labels
0378-0501-01, 0378-0501-10
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2026-05-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bisoprolol Fumarate and Hydrochlorothiazide - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2026-05-12HUMAN PRESCRIPTION DRUG LABEL
Bisoprolol Fumarate and Hydrochlorothiazide - REMEDYREPACK INC.REMEDYREPACK INC.2024-07-03HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-0501-01Bisoprolol Fumarate and Hydrochlorothiazide100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10015
0378-0501-05Bisoprolol Fumarate and Hydrochlorothiazide500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0501BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]15Current NDC, Legacy NDC, 2 package rows20240515_d4243a76-516c-417e-80ba-444a21ecc688.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0501-01EA - Each0378-05012aec6883-5d64-41f9-a457-516c8824074012012-07-24
0378-0501-05EA - Each0378-0501c2c07f14-9732-49cd-9c77-164e3625afec12021-04-08
0378-0501-10EA - Each0378-050123d08c3e-eb2c-4fd4-95b8-d58bccddf63612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISOPROLOL FUMARATEACTIVE INGREDIENTUR59KN573LBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4
BISOPROLOLACTIVE MOIETYY41JS2NL6UBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4

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 162 · 3,236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.5ee165a3-39a4-4d12-aff2-a6fb3309ce392026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Telmisartan and HydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDEAvKARE1b303136-dccd-178b-e063-6394a90a35f82026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.7dc3414b-dcb5-4b11-bca7-c0fa3f474aea2026-09-03Boxed warning, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEUmedica Laboratories USA Inc.55d6aee1-01ca-4791-8404-386664b4ab072026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
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
unii: UR59KN573L
unii: 0J48LPH2TH
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEREMEDYREPACK INC.57ffeef7-bfa8-4f92-aadc-23cd000226072026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEREMEDYREPACK INC.f20fd735-30c7-4f89-8ceb-b6186646eea62026-08-27Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
HydrochlorothiazideHYDROCHLOROTHIAZIDEREMEDYREPACK INC.8e0683e2-5473-4246-97ae-b71c21c39ac72026-08-26Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
HydrochlorothiazideHYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.8bc8d5e2-a974-64ed-e053-2a95a90a83402026-08-25Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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