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 4 of 141 · 2,805 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDESt. Mary's Medical Park Pharmacy57b0a1e5-5dfa-64a0-e063-6394a90acf362026-07-24Warnings, Adverse reactionsExact identifier
rxcui: 198052
unii: NMH84OZK2B
ONDANSETRONONDANSETRONHenry Schein, Inc.1a44601b-c31c-4779-a688-28cc4cc75e8b2026-07-23Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
ondansetron hydrochlorideONDANSETRON HYDROCHLORIDEIpca Laboratories Limited7ab3210e-eed1-479a-afc0-f72b5b7768832026-07-22Warnings, Adverse reactionsExact identifier
rxcui: 312086
rxcui: 198052
unii: NMH84OZK2B
ondansetronONDANSETRON HYDROCHLORIDEAscend Laboratories, LLC2edc0788-dc38-4d21-ba8e-71f159e2d3b12026-07-22Warnings, Adverse reactionsExact identifier
rxcui: 312086
rxcui: 198052
unii: NMH84OZK2B
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
ondansetronONDANSETRON HYDROCHLORIDECardinal Health 107, LLCcb02f2d7-31a9-4f12-880e-7ce7d85440d42026-07-17Warnings, Adverse reactionsExact identifier
application number: ANDA076183
rxcui: 312086
rxcui: 198052
unii: NMH84OZK2B
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEBryant Ranch Prepack3f2e8efe-7fd4-407c-a77b-bd6dd04608e22026-07-10Warnings, Adverse reactionsExact identifier
rxcui: 198052
unii: NMH84OZK2B
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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