FDA.reportPublic FDA data

NDC 80425-0227-01 - 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
80425-0227
Requested NDC
80425-0227-01
Package NDCs from labels
80425-0227-1, 80425-0227-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ondansetron - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0227-1Ondansetron10 in 1 BOTTLE, UNIT-DOSETABLET, ORALLY DISINTEGRATING103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0227ONDANSETRON TABLET, ORALLY DISINTEGRATING [ADVANCED RX PHARMACY OF TENNESSEE, LLC]3Current NDC, Legacy NDC, 1 package rows20250102_f1a0cd50-aa4f-55bc-e053-2995a90a2d3a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0227-1EA - Each80425-02276b0b97f9-0549-4145-81d9-0939a1e667a512023-06-06

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 6 of 12 · 221 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OndansetronONDANSETRON HYDROCHLORIDEAtlantic Biologics Corp.41d71d26-0d42-b368-e063-6394a90add432025-10-23Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
OndansetronONDANSETRONCardinal Health 107, LLC61758670-91ab-4422-8d9d-e8ca87eecae82025-10-23Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
OndansetronONDANSETRONLifsa Drugs LLCc66d63cf-a0e5-4cb5-bdf8-9d1115cba23e2025-10-13Warnings, Adverse reactionsExact identifier
unii: 4AF302ESOS
OndansetronONDANSETRONAmneal Pharmaceuticals LLC38435346-d505-4bdd-bbc6-a7bcba4110332025-09-23Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
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
OndansetronONDANSETRONFosun Pharma USA Inc.e3f22b7e-b6ad-4799-93c7-d30540cada852025-09-19Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
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
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
ONDANSETRONONDANSETRONApotex Corp.2c68d202-fdf7-4b6a-dd7f-82624fcdbd4a2025-08-26Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
OndansetronONDANSETRONCardinal Health 107, LLCb50c1767-8a50-49ab-be31-6533021ae7c42025-08-21Warnings, Adverse reactionsExact identifier
rxcui: 312087
unii: 4AF302ESOS
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.426ba54f-199a-41d1-8c27-f827bea568542025-08-15Warnings, Adverse reactionsExact identifier
rxcui: 198052
unii: NMH84OZK2B
OndansetronONDANSETRON HYDROCHLORIDENorthStar Rx LLCac3dfb81-a4c7-4147-9374-c234153b7c512025-08-11Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
OndansetronONDANSETRONGland Pharma Limited35716914-ac73-43c0-9aa0-09c99211d9412025-07-31Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B

Reported adverse events (FAERS/openFDA)#

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