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 5 of 138 · 2,754 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
ONDANSETRONONDANSETRONSportpharm LLCde72f1ec-75dd-4659-a1a0-32b28b72c7992026-07-02Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
unii: 15FIX9V2JP
Bambusa StannumBAMBUSA STANNUMUriel Pharmacy Inc.a0d4d0ac-e2d2-4381-8f93-e417195218592026-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
unii: 1K09F3G675
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
unii: 15FIX9V2JP
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
unii: 15FIX9V2JP
Sun Does Matter Daily Face SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDESundoesmatter Company Inc.553687d8-d4e1-8361-e063-6294a90a24fe2026-06-27WarningsExact identifier
unii: 15FIX9V2JP
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDESt. Mary's Medical Park Pharmacy58f16a00-3e66-29de-e053-2991aa0a59a02026-06-26Warnings, Adverse reactionsExact identifier
rxcui: 198052
unii: NMH84OZK2B
Ivory Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f25ba-61d5-6a94-e063-6394a90a46e92026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Simply Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f4799-9122-8db5-e063-6394a90a51322026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Vanilla Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f6d2c-9b8c-aa52-e063-6294a90a787e2026-06-26WarningsExact identifier
unii: 15FIX9V2JP
OndansetronONDANSETRONCardinal Health 107, LLC1b9c2d9f-62a8-4d26-a041-a598bc59e3002026-06-26Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERocky Mountain5515f562-62d9-c6ee-e063-6294a90a9ea62026-06-25WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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