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 19 of 41 · 815 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEPHOENIX RX LLC3a79fc2b-9ea3-a808-e063-6394a90ae7942025-09-22Warnings, Adverse reactionsExact identifier
rxcui: 198052
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEPHOENIX RX LLC40106070-6a25-5b0e-e063-6394a90a41972025-09-22Warnings, Adverse reactionsExact identifier
rxcui: 198052
unii: NMH84OZK2B
Vax-SodeTHUJA OCCIDENTALIS, CALCAREA CARBONICA, SILICEA, SALMONELLA TYPHI NOSODE, SERUM ANGUILLAE, BACILLUS TETANI, MALANDRINUM, MORBILLINUM, PAROTIDINUM, RUBELLA NOSODE, YERSINIA ENTEROCOLITICANutritional Specialties, Inc.cd570e98-c73f-4b38-b5b9-9f16f745ca192025-09-22WarningsExact identifier
unii: ETJ7Z6XBU4
OndansetronONDANSETRONFosun Pharma USA Inc.e3f22b7e-b6ad-4799-93c7-d30540cada852025-09-19Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
LibidoHYDRASTIS CANADENSIS, THUJA OCCIDENTALIS, AGNUS CASTUS, ARALIA QUINQUEFOLIA, BARYTA CARBONICA, BERBERIS VULGARIS, BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CAUSTICUM, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, CONIUM MACULATUM, GAULTHERIA PROCUMBENS, GRAPHITES, KALI CARBONICUM, LYCOPODIUM CLAVATUM, NUX VOMICA, ONOSMODIUM VIRGINIANUM, PHOSPHORUS, SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, SILICEA, STAPHYSAGRIANewton Laboratories, Inc.9c334fbd-0c1e-eac0-e053-2995a90a92832025-09-19WarningsExact identifier
unii: ETJ7Z6XBU4
LibidoHYDRASTIS CANADENSIS, THUJA OCCIDENTALIS, AGNUS CASTUS, ARALIA QUINQUEFOLIA, BARYTA CARBONICA, BERBERIS VULGARIS, BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CAUSTICUM, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, CONIUM MACULATUM, GAULTHERIA PROCUMBENS, GRAPHITES, KALI CARBONICUM, LYCOPODIUM CLAVATUM, NUX VOMICA, ONOSMODIUM VIRGINIANUM, PHOSPHORUS, SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, SILICEA, STAPHYSAGRIANewton Laboratories, Inc.9c348fa7-1d68-4975-e053-2995a90a0ca62025-09-19WarningsExact identifier
unii: ETJ7Z6XBU4
OndansetronONDANSETRONPD-Rx Pharmaceuticals, Inc.9558d296-8edd-4aa1-875a-6247f9a8374d2025-09-15Warnings, Adverse reactionsExact identifier
rxcui: 104894
unii: 4AF302ESOS
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.0b675b09-fe40-435c-b91a-c61cdf767fbf2025-09-15Warnings, Adverse reactionsExact identifier
rxcui: 312086
unii: NMH84OZK2B
OndansetronONDANSETRONPD-Rx Pharmaceuticals, Inc.10afd68b-877f-4819-a314-39f2d56d5db92025-09-15Warnings, Adverse reactionsExact identifier
rxcui: 312087
unii: 4AF302ESOS
Owell Naturals Draw Salve, Arnica, SiliceaARNICA MONTANA HPUS, SILICEA HPUSOwell Naturals Brand LLC1c9dab31-de1f-911b-e063-6294a90a03912025-09-12WarningsExact identifier
unii: ETJ7Z6XBU4
Owell Naturals Draw SalveARNICA MONTANA HPUS, SILICEA HPUSOwell Naturals Brand LLC1536ff1e-16b8-fbbc-e063-6394a90a628e2025-09-12WarningsExact identifier
unii: ETJ7Z6XBU4
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltd9083a01b-2fbe-4e04-9eec-bf4f65950ec72025-09-09WarningsExact identifier
unii: ETJ7Z6XBU4
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM ,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltdc14c79ab-85bb-45f2-83d1-1d9c298ffdfd2025-09-08WarningsExact identifier
unii: ETJ7Z6XBU4
OndansetronONDANSETRONPreferred Pharmaceuticals, Inc.b9abd5ce-6aca-4fda-8f46-0bb5b7fdd5da2025-09-04Warnings, Adverse reactionsExact identifier
rxcui: 312087
unii: 4AF302ESOS
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEPreferred Pharmaceuticals Inc.36d64400-2d13-4a1a-a1ca-4741cd3d3f1a2025-09-03Warnings, Adverse reactionsExact identifier
rxcui: 198052
unii: NMH84OZK2B
OndansetronONDANSETRONNorthStar Rx LLC9d5e7650-95be-4b96-b29c-374f673eb7a12025-09-03Warnings, Adverse reactionsExact identifier
rxcui: 312086
rxcui: 198052
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDERising Pharma Holdings, Inc.90e0e508-75f7-4c8b-bb38-898aa4c531c32025-09-01Warnings, Adverse reactionsExact identifier
rxcui: 312086
rxcui: 198052
unii: NMH84OZK2B
ONDANSETRONONDANSETRONProPharma Distribution3d5d25eb-8711-ef8c-e063-6394a90a5e032025-08-27Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
ONDANSETRONONDANSETRONApotex Corp.2c68d202-fdf7-4b6a-dd7f-82624fcdbd4a2025-08-26Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B

Reported adverse events (FAERS/openFDA)#

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