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 5 of 12 · 221 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDENorthwind Health Company, LLCf29f8ae1-4826-d8eb-e053-2a95a90a691a2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 312086
unii: NMH84OZK2B
OndansetronONDANSETRONNorthwind Health Company, LLCf2b502e2-03ed-fe5c-e053-2995a90a368e2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 312087
unii: 4AF302ESOS
OndansetronONDANSETRONNorthwind Health Company, LLCdb9a0d22-9339-4319-e053-2a95a90a95922026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 104894
unii: 4AF302ESOS
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDENorthwind Health Company, LLC852a3251-bf28-5557-e053-2991aa0a4fbd2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 198052
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDENorthwind Health Company, LLCdb99c77a-0b01-9da6-e053-2a95a90a51992026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 312086
unii: NMH84OZK2B
OndansetronONDANSETRONNorthwind Health Company, LLCe07c38c0-e1c2-01de-e053-2995a90a390a2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 312087
unii: 4AF302ESOS
OndansetronONDANSETRONNorthwind Health Company, LLCf29f5cfa-3cc4-7d53-e053-2995a90ae8442025-12-26Warnings, Adverse reactionsExact identifier
application number: ANDA078152
rxcui: 104894
unii: 4AF302ESOS
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
OndansetronONDANSETRONNatco Pharma USA LLC64527de5-0b92-4340-9243-7a37e8ff96d92025-12-19Warnings, Adverse reactionsExact identifier
rxcui: 312086
rxcui: 198052
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEQPharma, Inc.fbe71308-2927-2467-e053-6394a90aa4192025-12-16Warnings, Adverse reactionsExact identifier
rxcui: 312086
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEQPharma, Inc.2fa30bdb-f60e-40a7-98b4-c346bc85d5392025-12-15Warnings, Adverse reactionsExact identifier
rxcui: 198052
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEQPharma, Inc.dafe875e-391f-47a2-97b7-89840a760e442025-12-15Warnings, Adverse reactionsExact identifier
rxcui: 312086
unii: NMH84OZK2B
OndansetronONDANSETRONHospira, Inc.e0862c02-781f-4b10-ae50-9c9c4ca26f6d2025-12-01Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
OndansetronONDANSETRONAvKARE352de988-d166-c2d8-e063-6294a90acc012025-11-17Warnings, Adverse reactionsExact identifier
application number: ANDA078152
rxcui: 312087
rxcui: 104894
unii: 4AF302ESOS
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
OndansetronONDANSETRONBryant Ranch Prepack7949c245-b79f-4eaf-a75f-9a17bd7bd3072025-11-06Warnings, Adverse reactionsExact identifier
rxcui: 312087
unii: 4AF302ESOS
OndansetronONDANSETRONProficient Rx LP81366c85-c6c9-4a9a-9fe5-cdd8c2d19f742025-11-01Warnings, Adverse reactionsExact identifier
application number: ANDA078152
rxcui: 312087
rxcui: 104894
unii: 4AF302ESOS
ondansetronONDANSETRONAccord Healthcare, Inc.35e0d160-813f-41d7-a382-d2cab6485d9c2025-10-29Warnings, Adverse reactionsExact identifier
unii: 4AF302ESOS

Reported adverse events (FAERS/openFDA)#

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