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 1 of 12 · 224 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEREMEDYREPACK INC.960e2104-18c3-4cfa-abf6-f1b30c4529182026-09-08Warnings, Adverse reactionsExact identifier
rxcui: 198052
unii: NMH84OZK2B
OndansetronONDANSETRONREMEDYREPACK INC.416be720-82e8-4a6d-8531-c1a29869daae2026-09-01Warnings, Adverse reactionsExact identifier
rxcui: 312086
unii: NMH84OZK2B
OndansetronONDANSETRONAsclemed USA, Inc.269c920c-643a-4eea-9bf9-b1f008915db92026-08-28Warnings, Adverse reactionsExact identifier
rxcui: 104894
unii: 4AF302ESOS
OndansetronONDANSETRONSt. Mary's Medical Park Pharmacyf175a336-433b-7ab2-e053-2995a90ad5ca2026-08-26Warnings, Adverse reactionsExact identifier
application number: ANDA078152
rxcui: 104894
unii: 4AF302ESOS
ondansetronONDANSETRON HYDROCHLORIDEMajor Pharmaceuticalsa29b5c18-9884-4c88-8827-65d9ad5f69f62026-08-21Warnings, Adverse reactionsExact identifier
rxcui: 312086
rxcui: 198052
unii: NMH84OZK2B
ondansetronONDANSETRON HYDROCHLORIDEBryant Ranch Prepack37de0550-a6d1-46a8-a0b8-447b0dcf70ad2026-08-19Warnings, Adverse reactionsExact identifier
rxcui: 312086
rxcui: 198052
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEUnit Dose Solutions, Inc.5566aebb-d84d-6d6a-e063-6294a90a746f2026-08-18Warnings, Adverse reactionsExact identifier
rxcui: 198052
unii: NMH84OZK2B
OndansetronONDANSETRONREMEDYREPACK INC.c0d827d0-333f-4187-ac75-9dc7d34b61692026-08-11Warnings, Adverse reactionsExact identifier
application number: ANDA078152
rxcui: 104894
unii: 4AF302ESOS
OndansetronONDANSETRONPreferred Pharmaceuticals, Inc.66ac9c17-bea7-4f8d-8a27-a1e0f9e659452026-08-07Warnings, Adverse reactionsExact identifier
rxcui: 104894
unii: 4AF302ESOS
OndansetronONDANSETRONPreferred Pharmaceuticals Inc.7975d78c-9bb6-467a-9c2d-ea15bde7af5c2026-08-07Warnings, Adverse reactionsExact identifier
application number: ANDA078152
rxcui: 104894
unii: 4AF302ESOS
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEPreferred Pharmaceuticals Inc.2a30d534-4607-4882-865e-56d2364acaad2026-08-07Warnings, Adverse reactionsExact identifier
rxcui: 312086
unii: NMH84OZK2B
OndansetronONDANSETRONPreferred Pharmaceuticals, Inc.70b48280-ef74-472b-abc3-128962bfcb052026-08-07Warnings, Adverse reactionsExact identifier
rxcui: 312087
unii: 4AF302ESOS
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEPreferred Pharmaceuticals, Inc.14276805-4e99-4bbe-ad76-ffc06eddb38a2026-08-06Warnings, Adverse reactionsExact identifier
rxcui: 312086
rxcui: 198052
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDESt. Mary's Medical Park Pharmacy00b17a8e-9d38-a8d4-e063-6294a90a153e2026-08-05Warnings, Adverse reactionsExact identifier
rxcui: 312086
unii: NMH84OZK2B
OndansetronONDANSETRONSportpharm LLC3c4cda2f-13d9-42c5-b449-77deb06c8de52026-08-03Warnings, Adverse reactionsExact identifier
rxcui: 312087
unii: 4AF302ESOS
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEProficient Rx LP0a14eb9a-0385-40e9-a7ec-71435450ac912026-08-01Warnings, Adverse reactionsExact identifier
rxcui: 198052
unii: NMH84OZK2B
OndansetronONDANSETRONA-S Medication Solutions5a81a39b-051b-414e-a6b0-d844de4e9ab42026-07-29Warnings, Adverse reactionsExact identifier
application number: ANDA078152
rxcui: 312087
rxcui: 104894
unii: 4AF302ESOS
OndansetronONDANSETRONA-S Medication Solutions02ddd5f5-76d3-4f1c-9af3-d39e05a19c292026-07-29Warnings, Adverse reactionsExact identifier
application number: ANDA078152
rxcui: 104894
unii: 4AF302ESOS
OndansetronONDANSETRONSt. Mary's Medical Park Pharmacy41366a20-0727-0446-e063-6294a90a957f2026-07-28Warnings, Adverse reactionsExact identifier
application number: ANDA078152
rxcui: 312087
unii: 4AF302ESOS
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDESt. Mary's Medical Park Pharmacy57b0a1e5-5dfa-64a0-e063-6394a90acf362026-07-24Warnings, Adverse reactionsExact identifier
rxcui: 198052
unii: NMH84OZK2B

Reported adverse events (FAERS/openFDA)#

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