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 2 of 161 · 3,212 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack53221419-204c-40a2-9ec3-8e4b994dd39d2026-08-20Warnings, Adverse reactionsExact identifier
rxcui: 854916
unii: UR59KN573L
unii: 0J48LPH2TH
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEA-S Medication Solutions12ba7eba-1874-41b6-aff5-7baba8b999842026-08-20Warnings, Adverse reactionsExact identifier
rxcui: 854919
unii: UR59KN573L
unii: 0J48LPH2TH
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack154cb1d2-9fb2-4c8d-90de-6a8062a8d1ba2026-08-19Warnings, Adverse reactionsExact identifier
rxcui: 854919
unii: UR59KN573L
unii: 0J48LPH2TH
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
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
unii: UR59KN573L
unii: 0J48LPH2TH
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
unii: UR59KN573L
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSREMEDYREPACK INC.3bea11a3-eb07-46b2-9b91-f8a48a2f3b7e2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

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