FDA.reportPublic FDA data

NDC 0955-1045-30 - Irbesartan 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
0955-1045
Requested NDC
0955-1045-30
Package NDCs from labels
0955-1045-90, 0955-1045-30
Manufacturer
Bryant Ranch Prepack
Effective date
2024-05-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Irbesartan and Hydrochlorothiazide - Bryant Ranch PrepackBryant Ranch Prepack2024-05-20HUMAN PRESCRIPTION DRUG LABEL
Irbesartan and HydrochlorothiazideWinthrop U.S, a business of sanofi-aventis U.S. LLC | Sanofi Chimie | EUROAPI Hungary Ltd. | Eurofins Lancaster Laboratories, Inc | CAMBREX PROFARMACO MILANO S.R.L. | Sanofi Winthrop Industrie2023-12-07HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0955-1045-902024-12-06C16284748780-11030e365-4ac3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use Irbesartan and Hydrochlorothiazide safely and effectively. See full prescribing information for Irbesartan and Hydrochlorothiazide. Irbesartan and Hydrochlorothiazide tablets, for oral use Initial U.S. Approval: 1997
0955-1045-902024-07-30C16284748780-11030e365-4ac3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use Irbesartan and Hydrochlorothiazide safely and effectively. See full prescribing information for Irbesartan and Hydrochlorothiazide. Irbesartan and Hydrochlorothiazide tablets, for oral use Initial U.S. Approval: 1997
0955-1045-902024-01-30C16284748780-11030e365-4ac3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use Irbesartan and Hydrochlorothiazide safely and effectively. See full prescribing information for Irbesartan and Hydrochlorothiazide. Irbesartan and Hydrochlorothiazide tablets, for oral use Initial U.S. Approval: 1997

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0955-1045-30EA - Each0955-1045564317d9-a135-473f-8c3e-42f62d4be94512012-07-24
0955-1045-90EA - Each0955-10458f432867-bf49-4aa1-9723-bf789d94bbaf12012-07-24

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 4 of 161 · 3,213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bisoprolol fumarate and hydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEUnichem Pharmaceuticals (USA), Inc.b9ee689a-ea12-435d-b01c-70d45891e62f2026-08-06Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
IrbesartanIRBESARTANMacleods Pharmaceuticals Limitede8635a1c-ae06-4e23-99f7-e704f91d6f432026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
IRBESARTANIRBESARTANHisun Pharmaceuticals USA Inc.61ab1b6e-c849-49ca-a3f0-150774db649d2026-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
ROROBELL WAWA Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEROROBELL58336a0d-49dd-ef13-e063-6394a90a38c12026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
Silicea 6XSILICON DIOXIDEHyland's Inc.db4be3c1-aa7e-24a2-e053-2a95a90a0c662026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSProficient Rx LP43a4d6dd-bcca-412c-b051-ed470208ddb62026-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEViona Pharmaceuticals Inc57505d73-f2a8-430b-8703-a0a6bb733c7d2026-07-31Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
SmogstatECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEAEnergique, Inc.59f63e2b-24fa-43a0-8334-02e6729c6ac12026-07-31WarningsExact identifier
unii: ETJ7Z6XBU4
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack167f49f0-2d39-49a2-9f9e-1359a7c7ba3d2026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDEScieGen Pharmaceuticals, INC.17362ff8-07bb-42c6-a100-8adb93be03482026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
IrbesartanIRBESARTANREMEDYREPACK INC.5b259fdd-ca4c-49c9-a50d-86066f5b07462026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.9f9cd7a7-be95-4ea8-8247-eb7ecbd369362026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

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