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 26 of 41 · 805 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OndansetronONDANSETRONAdvanced Rx of Tennessee, LLC2a8603a9-5b6f-b921-e063-6394a90ae29c2024-12-29Warnings, Adverse reactionsExact identifier
application number: ANDA078152
rxcui: 104894
unii: 4AF302ESOS
OndansetronONDANSETRONAdvanced Rx of Tennessee, LLC2a863485-a0a8-db63-e063-6294a90ab6052024-12-29Warnings, Adverse reactionsExact identifier
rxcui: 104894
unii: 4AF302ESOS
Trace Mineral CordARGENTUM METALLICUM, AURUM METALLICUM, BORON CITRATE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CHROMIUM SULPHURICUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERRUM PHOSPHORICUM, GERMANIUM SESQUIOXIDE, IODIUM, KALI BROMATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, LITHIUM CARBONICUM, MAGNESIA PHOSPHORICA, MANGANUM MURIATICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SELENIUM METALLICUM, SILICEA, SODIUM MOLYBDATE, STRONTIUM CARBONICUM, VANADIUM METALLICUM,Energique, Inc.902dd68d-5ce1-481e-8938-6487dcc68dfc2024-12-19WarningsExact identifier
unii: ETJ7Z6XBU4
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEQuality Care Products, LLC2e0b1b09-9e68-4728-82d5-1f86510a0f2a2024-12-19Warnings, Adverse reactionsExact identifier
rxcui: 198052
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEQuality Care Products LLC54e8981e-6880-4d4f-bc46-600c2af596982024-12-18Warnings, Adverse reactionsExact identifier
rxcui: 312086
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEQuality Care Products LLC89091629-d15e-4e95-aed8-8bc983c783022024-12-18Warnings, Adverse reactionsExact identifier
rxcui: 198052
unii: NMH84OZK2B
GeovitaCEREBRUM, CUPRUM MET, FERRUM MET, FORMICUM ACIDUM, SILICEARUBIMED AG0fcb5c06-d414-456c-a0ef-28e14018a7812024-11-29WarningsExact identifier
unii: ETJ7Z6XBU4
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d41602-9dcb-eaa8-e063-6394a90a7cfa2024-11-26WarningsExact identifier
unii: ETJ7Z6XBU4
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHEIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d4ddaf-9c07-a7fc-e063-6394a90adc0b2024-11-26WarningsExact identifier
unii: ETJ7Z6XBU4
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d5997b-1cae-41c2-e063-6394a90ac74a2024-11-26WarningsExact identifier
unii: ETJ7Z6XBU4
Hempvana Ultra Pain Relief Homeopathic Cream Platinum - Nerve ReliefARNICA MONTANA, ACONITUM NAPELLUS, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, SECALE CORNUTUM, SILICEATELEBRANDS CORP2787f88c-752e-cbaa-e063-6394a90a732c2024-11-21WarningsExact identifier
unii: ETJ7Z6XBU4
Hempvana Ultra Pain Relief - Nerve ReliefARNICA MONTANA, ACONITUM NAPELLUS, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, SECALE CORNUTUM, SILICEATELEBRANDS CORPf93a1ed0-5046-0355-e053-6294a90a6a902024-11-20WarningsExact identifier
unii: ETJ7Z6XBU4
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUMEnergetix Corporation37063a49-6b45-4167-875d-49c9dac3f79b2024-11-20WarningsExact identifier
unii: ETJ7Z6XBU4
MammaryplexECHINACEA (ANGUSTIFOLIA), MYRRHA, TRIGONELLA FOENUM-GRAECUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, LYMPH (SUIS), SPLEEN (SUIS), BRYONIA (ALBA), CONIUM MACULATUM, LAC CANINUM, LACHESIS MUTUS, SILICEA, BUFO RANA, MAMMARY GLAND (BOVINE)BioActive Nutritional, Inc.2be630bc-9fa6-42a6-b66d-99f91a58b1fa2024-11-15WarningsExact identifier
unii: ETJ7Z6XBU4
FocusADENOSINUM CYCLOPHOSPHORICUM, ADRENALINUM, AETHUSA CYNAPIUM, ALPHA-KETOGLUTARICUM ACIDUM, AMBRA GRISEA, BARYTA CARBONICA, CANDIDA ALBICANS, CARBONEUM SULPHURATUM, CEREBRUM SUIS, GINKGO BILOBA, HELLEBORUS NIGER, HYPOTHALAMUS SUIS, HYOSCYAMUS NIGER, IODIUM, PHOSPHORUS, SACCHARUM OFFICINALE, SARCOLACTICUM ACID, SILICEA, TARENTULA HISPANA, VERATRUM ALBUMDeseret Biologicals, Inc.e014e6b6-a07a-4170-b9af-f477da71597d2024-11-13WarningsExact identifier
unii: ETJ7Z6XBU4
ChronagesicALPHA-LIPOICUM ACIDUM, APIOLUM, ARNICA MONTANA, CARTILAGO SUIS, CINNAMOMUM, DULCAMARA, FUNICULUS UMBILICALIS SUIS, NADIDUM, NATRUM OXALACETICUM, PANTOTHENIC ACID, PLACENTA TOTALIS SUIS, PIPER NIGRUM, RHUS TOX, SANGUINARIA CANADENSIS, SULPHUR, SILICEA, SYMPHYTUM OFFICINALE, THUJA OCCIDENTALISDeseret Biologicals, Inc.1e340282-dbd9-44d7-9924-807f4099cf0c2024-11-08WarningsExact identifier
unii: ETJ7Z6XBU4
Sinus Congestion HeadacheANTIMONIUM TARTARICUM, ASAFOETIDA, BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, EUPHORBIA PILULIFERA, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, IODIUM, KALI BICHROMICUM, LACHESIS MUTUS, MAGNESIA CARBONICA, MUCOSA NASALIS SUIS, PULSATILLA (PRATENSIS), PYROGENIUM, SILICEA, TEUCRIUM MARUMLiddell Laboratories, Inc.debc7747-8664-4598-a862-e295188c4fca2024-11-04WarningsExact identifier
unii: ETJ7Z6XBU4
VaccinesARNICA MONTANA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MORBILLINUM, NATRUM MURIATICUM, SILICEA, SULPHUR IODATUM, THUJA OCCIDENTALIS, URTICA URENSLiddell Laboratories, Inc.6e6e67d4-089e-4775-b4a4-5511953f6e3f2024-11-04WarningsExact identifier
unii: ETJ7Z6XBU4
VaccistatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ALUMINA, ANTIMONIUM TARTARICUM, MEZEREUM, NATRUM MURIATICUM, MERCURIUS SOLUBILIS, SILICEA, THUJA OCCIDENTALIS, MALANDRINUM, VARIOLINUMEnergique, Inc.8c8d63b6-763a-44f8-87ef-e83a89ec37762024-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
VaccistatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ALUMINA, ANTIMONIUM TARTARICUM, MEZEREUM, NATRUM MURIATICUM, MERCURIUS SOLUBILIS, SILICEA, THUJA OCCIDENTALIS, MALANDRINUM, VARIOLINUMEnergique, Inc.5205cc3e-c9bc-48e9-9c9b-959a9be78b852024-10-31WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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