FDA.reportPublic FDA data

NDC 70518-3512-01 - 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
70518-3512
Requested NDC
70518-3512-01
Package NDCs from labels
70518-3512-0, 70518-3512-1, 70518-3512-2, 70518-3512-3, 70518-3512-4, 70518-3512-5, 70518-3512-6, 70518-3512-7, 70518-3512-8, 70518-3512-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-08-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ondansetron - REMEDYREPACK INC.REMEDYREPACK INC.2026-08-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3512-0Ondansetron30 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING3013
70518-3512-1Ondansetron6 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING613
70518-3512-2Ondansetron10 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING1013
70518-3512-3Ondansetron20 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING2013
70518-3512-4Ondansetron12 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING1213
70518-3512-5Ondansetron9 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING913
70518-3512-6Ondansetron21 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING2113
70518-3512-7Ondansetron15 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING1513
70518-3512-8Ondansetron3 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING313

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3512ONDANSETRON TABLET, ORALLY DISINTEGRATING [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 9 package rows20250313_c0d827d0-333f-4187-ac75-9dc7d34b6169.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3512-0EA - Each70518-3512c09bb726-6922-454a-85e3-77953f31aaa812026-01-08

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 14 of 41 · 815 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
muscles and jointsCALC FLUOR, CALC PHOS, CARPINUS BETULUS, FLOS, ILEX AQUIFOLIUM, FLOS, KALI SULPH, MAG PHOS, NAT PHOS, QUERCUS ROBUR, FLOS, SILICEASiddha Flower Essences LLC421e61e4-f9df-48e1-bff3-80148a5de5cf2025-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
ONETOOTHCLINIC TOOTHSILICON DIOXIDE, TOCOPHEROL ACETATE, SODIUM PYROPHOSPHATECONE MEDICAL Co., Ltd.9a567c9e-b8ce-7bf1-e053-2995a90aff2b2025-12-30WarningsExact identifier
unii: ETJ7Z6XBU4
ONETOOTH CLINIC TOOTHSILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATECONE MEDICAL Co., Ltd.bd50abcd-8a85-2923-e053-2995a90a109b2025-12-30WarningsExact identifier
unii: ETJ7Z6XBU4
OndansetronONDANSETRONNorthwind Health Company, LLCf29f5cfa-3cc4-7d53-e053-2995a90ae8442025-12-26Warnings, Adverse reactionsExact identifier
application number: ANDA078152
rxcui: 104894
unii: 4AF302ESOS
StellaLife VEGA Oral CareSPRAYStellaLife, Inc.b8ba495e-2cfe-092c-e053-2995a90a3fd32025-12-24WarningsExact identifier
unii: ETJ7Z6XBU4
StellaLife VEGA Oral Care Recovery KitKITHomeocare Laboratories, Inc.b701234a-0bd2-16d3-e053-2995a90a5b132025-12-24WarningsExact identifier
unii: ETJ7Z6XBU4
OndansetronONDANSETRONRedpharm Drug300b1916-a3d8-0220-e063-6394a90a6f552025-12-23Warnings, Adverse reactionsExact identifier
rxcui: 198052
unii: NMH84OZK2B
OndansetronONDANSETRONIpca Laboratories Limited8e24f935-87fe-4b6a-b265-60b1039f38d52025-12-22Warnings, Adverse reactionsExact identifier
rxcui: 312087
rxcui: 104894
unii: 4AF302ESOS
StellaLife VEGA Oral Care Peppermint Pain and Swelling ReliefARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, LEDUM PALUSTRE, RUTA, SILICEA, STAPHYSAGRIAStellaLife, Inc.10d42c12-713a-f461-e063-6294a90a223b2025-12-22WarningsExact identifier
unii: ETJ7Z6XBU4
StellaLife VEGA Oral Care Pain and Swelling ReliefARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, RUTA, STAPHYSAGRIAStellaLife, Inc.10f8dee1-d5d3-0602-e063-6294a90a6dbf2025-12-22WarningsExact identifier
unii: ETJ7Z6XBU4
OndansetronONDANSETRONNatco Pharma USA LLC64527de5-0b92-4340-9243-7a37e8ff96d92025-12-19Warnings, Adverse reactionsExact identifier
rxcui: 312086
rxcui: 198052
unii: NMH84OZK2B
SominezeHUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEABioActive Nutritional, Inc.c0f80b84-0dd5-416b-abdf-8a0412e0b40b2025-12-18WarningsExact identifier
unii: ETJ7Z6XBU4
Vaccine Support CPBELLADONNA, CALCAREA CARBONICA, CARCINOSINUM, HYPERICUM PERFORATUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MALANDRINUM, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, PYROGENIUM, SARSAPARILLA, SILICEA, SULPHUR, THUJA OCCIDENTALISNatural Creations, Incb99f6b65-fe22-4dc2-97f8-8ab315396f752025-12-18WarningsExact identifier
unii: ETJ7Z6XBU4
SCROPHULOUS HPBARYTA CARBONICA, BROMIUM, CALCAREA CARBONICA, FERRUM IODATUM, MERCURIUS SOLUBILIS, PHYTOLACCA DECANDRA, RHUS TOX, SILICEABioActive Nutritional, Inc.3421f76b-bcde-42b5-a04b-05099520e6612025-12-18WarningsExact identifier
unii: ETJ7Z6XBU4
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUMEnergetix Corporation9b532a31-530a-44f9-843f-f395a3e460b82025-12-17WarningsExact 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 SULFURWalgreen Companyd8c7ec58-5453-0e58-e053-2995a90abff12025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4
Pan-Zyme-SPANCREAS BALANCEVitality Works, Inc.4f6e18ca-719c-445e-9dad-fc40ad9e1aeb2025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4
RPT-SysEMOTIONAL REBALANCEVitality Works, Inc.0e8768fe-c2ba-41e9-93ac-c142fae6e8792025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4
DigestivEaseARSENICUM ALB, CALC SULPH, CARBO AN, CARBO VEG, CINCHONA, HYDRASTIS, NOX VOM, ORNITHOGALUM, PYROGENIUM, SILICEAEight and Company L.L.C70840ff7-75c0-44a0-9eb8-b36f13518af22025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEQPharma, Inc.fbe71308-2927-2467-e053-6394a90aa4192025-12-16Warnings, Adverse reactionsExact identifier
rxcui: 312086
unii: NMH84OZK2B

Reported adverse events (FAERS/openFDA)#

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