FDA.reportPublic FDA data

NDC 55111-154-79 - ondansetron

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
55111-154
Requested NDC
55111-154-79
Package NDCs from labels
55111-154-30, 55111-154-01, 55111-154-05, 55111-154-79, 55111-154-78, 55111-154-13
Manufacturer
Major Pharmaceuticals
Effective date
2026-08-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ondansetron - Major PharmaceuticalsMajor Pharmaceuticals2026-08-21HUMAN PRESCRIPTION DRUG LABEL
ONDANSETRON - Dr. Reddy's Laboratories Limited | Dr. Reddy's Laboratories Limited-FTO IIIDr. Reddy's Laboratories Limited | Dr. Reddy's Laboratories Limited-FTO III2025-06-30HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
55111-154-012020-05-14These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
55111-154-052020-05-14These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
55111-154-132020-05-14These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
55111-154-302020-05-14These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
55111-154-782020-05-14These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
55111-154-012020-01-31These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
55111-154-052020-01-31These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
55111-154-132020-01-31These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
55111-154-302020-01-31These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
55111-154-782020-01-31These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-154-01ONDANSETRON100 in 1 BOTTLETABLET, FILM COATED10017
55111-154-05ONDANSETRON500 in 1 BOTTLETABLET, FILM COATED50017
55111-154-13ONDANSETRON1 in 1 DOSE PACKTABLET, FILM COATED117
55111-154-13ONDANSETRON3 in 1 BOXTABLET, FILM COATED317
55111-154-30ONDANSETRON30 in 1 BOTTLETABLET, FILM COATED3017
55111-154-78ONDANSETRON10 in 1 BOXTABLET, FILM COATED1017
55111-154-79ONDANSETRON10 in 1 DOSE PACKTABLET, FILM COATED1017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-154ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]16Current NDC, Legacy NDC, 7 package rows20250315_162f2088-9fb1-47e7-b88c-45104be7e7bb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-154-13EA - Each55111-15402f339ec-31b3-4cff-89dd-e46f5ec46bc812012-07-24
55111-154-30EA - Each55111-1548b0a7620-e053-4909-943a-4bff58d37a4212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8
magnesium stearateINACTIVE INGREDIENT70097M6I30ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8

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 9 of 138 · 2,754 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEABM Private Limited5331dc40-2ac8-5fce-e063-6394a90a58752026-06-01WarningsExact identifier
unii: ETJ7Z6XBU4
KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREENTITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc294e6049-12b5-4b45-ae00-8ee1d9d2a1a42026-05-29WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE AND ZINC OXIDEPharma Nobis, LLCfbcfa541-beda-06de-e053-6294a90a92982026-05-26WarningsExact identifier
unii: 1K09F3G675
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.52ba9423-8b9b-38f7-e063-6394a90a95da2026-05-26WarningsExact identifier
unii: 15FIX9V2JP
OndansetronONDANSETRONHospira, Inc.d62cd60b-f87e-4825-bead-1d18bbc4e4802026-05-23Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
OndansetronONDANSETRONHospira, Inc.6a11f61b-2318-4382-2b91-4366e4bb53fa2026-05-22Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Mineral SPF 30 MoisturizerMINERAL SPF 30 MOISTURIZERDont Run Out Inc (DBA: Public Goods)52462e7e-0c2c-6b64-e063-6394a90a42302026-05-21WarningsExact identifier
unii: 15FIX9V2JP
DRMTLGY Radiance PowderTITANIUM DIOXIDE, ZINC OXIDEDRMTLGY15bda8d5-8c3c-6ba5-e063-6394a90a82d92026-05-21WarningsExact identifier
unii: 15FIX9V2JP
SkinCeuticals Future Mineral UV Defense Invisble Sunscreen Mineral Filters Broad Spectrum SPF 50TITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc0b92a940-0dd4-4266-bd47-88c27def62c02026-05-20WarningsExact identifier
unii: 15FIX9V2JP
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 15FIX9V2JP
IT COSMETICS HELLO SUNSHINE Invisible Sunscreen Broad Spectrum SPF 50 UVA UVB Mineral 50TITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc.fded7dfb-ffb9-4fb0-9511-273e0e1269692026-05-20WarningsExact identifier
unii: 15FIX9V2JP
Freaks of Nature Peak Performance Broad Spectrum SPF 50FREAKS OF NATURE PEAK PERFORMANCE BROAD SPECTRUM SPF 50THE FREAKS OF NATURE, INC.5247187d-a14c-6468-e063-6394a90ace3e2026-05-20WarningsExact identifier
unii: 15FIX9V2JP
DentaforceANTIMONIUM CRUDUM, BELLADONNA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, SEPIA, SILICEA, HYDROFLUORICUM ACIDUMBioActive Nutritional, Inc.82321547-e04a-42ff-aa39-6a192638e5a22026-05-18WarningsExact identifier
unii: ETJ7Z6XBU4
LANCOME PARIS UV EXPERT SUPRA SCREEN MINERAL INVISIBLE SUNSCREEN SPF 50 SERUMTITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc.23cc5ff4-f842-4e3e-ac5c-23dbaf7d39142026-05-15WarningsExact identifier
unii: 15FIX9V2JP
LANCOME PARIS UV EXPERT SUPRA SCREEN MINERAL INVISIBLE SUNSCREEN SPF 50 SERUMTITANIUM DIOXIDE AND ZINC OXIDESICOS ET CIEc688f8e6-2cd2-40db-b03f-90fd74c2d89c2026-05-15WarningsExact identifier
unii: 15FIX9V2JP
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc7df9dbd2-7db9-4961-819d-e93d14a065c32026-05-15WarningsExact identifier
unii: 15FIX9V2JP
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE20efd5fa-3077-4fd4-82d0-ddca946e45282026-05-15WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenOCTOCRYLENE,HOMOSALATE,ETHYLHEXYL SALICYLATE,PHENYLBENZIMIDAZOLE SULFONIC ACID,BUTYL METHOXYDIBENZOYLMETHANE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd51c353cb-94c4-e110-e063-6394a90a497e2026-05-14WarningsExact identifier
unii: 15FIX9V2JP
C07 STRONG LIGAMENTS AND JOINTSARNICA MONTANA, ASCORBICUM ACIDUM, BOS TAURUS LYMPH VESSEL, INTERVERTEBRAL FIBROCARTILAGE, BOS TAURUS MESENCHYME, CALCAREA PHOSPHORICA, CARTILAGO SUIS, FORMICUM ACIDUM, LAPIS ALBUS, PINUS MONTANA LEAFY TWIG, RHAMNUS CALIFORNICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SUS SCROFA JOINT ENVELOPE, SUS SCROFA LIGAMENT, SUS SCROFA MENISCUS, SUS SCROFA PARATHYROID GLAND, SUS SCROFA VEIN, SYMPHYTUM OFFICINALEApex Energetics Inc.bccf8c83-a6cd-e58c-e053-2a95a90a43d72026-05-13WarningsExact identifier
unii: ETJ7Z6XBU4
Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - DarkTITANIUM DIOXIDE AND ZINC OXIDESENT, Inc.aedde765-931f-430e-9fc3-d87bde2b78cd2026-05-12WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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