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 17 of 41 · 815 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dizziness HPCALCAREA CARBONICA, CHENOPODIUM ANTHELMINTICUM, COCCULUS INDICUS, CONIUM MACULATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, TABACUM,Energique, Inc.0bf53ecc-c2ad-40b5-b921-7c10a1b006262025-11-19WarningsExact identifier
unii: ETJ7Z6XBU4
OndansetronONDANSETRONAvKARE352de988-d166-c2d8-e063-6294a90acc012025-11-17Warnings, Adverse reactionsExact identifier
application number: ANDA078152
rxcui: 312087
rxcui: 104894
unii: 4AF302ESOS
Formica Stibium comp.FORMICA STIBIUM COMP.Uriel Pharmacy Inc.439073f2-1dee-4b4e-a65e-74aee1c73c2b2025-11-17WarningsExact identifier
unii: ETJ7Z6XBU4
Lavender Quartz Ear OilLAVENDER QUARTZ EAR OILUriel Pharmacy Inc.b1a8d75c-77a9-40a7-8dd8-9c32cac31d2c2025-11-17WarningsExact identifier
unii: ETJ7Z6XBU4
Polygonatum CepaPOLYGONATUM CEPAUriel Pharmacy Inc.6ba0ac36-16cc-49bd-b37f-90cf18acbd5a2025-11-17WarningsExact identifier
unii: ETJ7Z6XBU4
ondansetron hydrochlorideONDANSETRON HYDROCHLORIDEOnesource Specialty Pharma Limited438c3d28-8bed-50f0-e063-6394a90a18e42025-11-14Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
ondansetron hydrochlorideONDANSETRON HYDROCHLORIDEOnesource Specialty Pharma Limiteda5fe05bc-a7a5-4131-8c4d-2edd113441ec2025-11-14Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Bambusa Viscum StannumBAMBUSA VISCUM STANNUMUriel Pharmacy Inc.7b2a95d0-6f51-4a6b-b05f-fe7d13d83b892025-11-14WarningsExact identifier
unii: ETJ7Z6XBU4
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
BELLA HPATROPA BELLADONNA, CONIUM MACULATUM FLOWERING TOP, SOLANUM DULCAMARA TOP, CALCIUM SULFIDE, POTASSIUM DICHROMATE, MERCURIUS SOLUBILIS, ANEMONE PULSATILLA, SILICON DIOXIDE, MATRICARIA RECUTITA.Natural Creations, Inc.8e46906b-9c22-4a8e-ae4e-f1fbfb3d35b12025-11-13WarningsExact identifier
unii: ETJ7Z6XBU4
BONE HPSODIUM BORATE, OYSTER SHELL CALCIUM CARBONATE CRUDE, CALCIUM FLUORIDE, TRIBASIC CALCIUM PHOSPHATE, EUPATORIUM PERFOLIATUM FLOWERING TOP, IRON, HYDROFLUORIC ACID, HEKLA LAVA, TOXICODENDRON PUBESCENS LEAF, RUTA GRAVEOLENS FLOWERING TOP, SILICON DIOXIDE, COMFREY ROOT.Natural Creations, Inc.93d2b385-9ce3-4d16-b428-1638e9a55f922025-11-13WarningsExact identifier
unii: ETJ7Z6XBU4
LUMOe SKIN1 Skin RemedyKALI MURIATICUM, PRUNUS SPINOSA, SILICEA, SARSAPARILLAApplied Bioenergetics, LLCd4d7fd2f-66bf-407d-ad36-2462e880b9f52025-11-10WarningsExact identifier
unii: ETJ7Z6XBU4
Ananassa ResinaANANASSA RESINAUriel Pharmacy Inc.52a18d0a-2c97-4e81-81ff-c836582d0a4c2025-11-07WarningsExact identifier
unii: ETJ7Z6XBU4
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
OndansetronONDANSETRONBryant Ranch Prepack7949c245-b79f-4eaf-a75f-9a17bd7bd3072025-11-06Warnings, Adverse reactionsExact identifier
rxcui: 312087
unii: 4AF302ESOS
Teething-ColicCHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALENewton Laboratories, Inc.9db30229-3031-ff10-e053-2995a90aff752025-11-06WarningsExact identifier
unii: ETJ7Z6XBU4
Teething-ColicCHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALENewton Laboratories, Inc.9db4790e-28c2-2dce-e053-2a95a90ae7922025-11-06WarningsExact identifier
unii: ETJ7Z6XBU4
OndansetronONDANSETRONProficient Rx LP81366c85-c6c9-4a9a-9fe5-cdd8c2d19f742025-11-01Warnings, Adverse reactionsExact identifier
application number: ANDA078152
rxcui: 312087
rxcui: 104894
unii: 4AF302ESOS
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A

Reported adverse events (FAERS/openFDA)#

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