FDA.reportPublic FDA data

NDC 80425-0228-01 - 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
80425-0228
Requested NDC
80425-0228-01
Package NDCs from labels
80425-0228-1, 80425-0228-2, 80425-0228-3, 80425-0228-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2025-05-30
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, LLC2025-05-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0228-1Ondansetron3 in 1 CARTONTABLET, ORALLY DISINTEGRATING36
80425-0228-1Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING106
80425-0228-2Ondansetron2 in 1 CARTONTABLET, ORALLY DISINTEGRATING26
80425-0228-2Ondansetron3 in 1 CARTONTABLET, ORALLY DISINTEGRATING36
80425-0228-3Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0228ONDANSETRON TABLET, ORALLY DISINTEGRATING [ADVANCED RX PHARMACY OF TENNESSEE, LLC]5Current NDC, 5 package rows20240224_f1a0b9ee-c1d2-7818-e053-2995a90a3e96.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0228-1EA - Each80425-0228fa25cf8c-1b2c-4fa0-a25f-e449a12dc05512023-04-07
80425-0228-2EA - Each80425-0228be69a6f8-bffd-4c20-b029-ee37c66a28e312023-06-06
80425-0228-3EA - Each80425-0228d416152b-61d5-41ee-b10c-d0ebec5d3c5112024-03-12

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 5 · 83 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ONDANSETRONONDANSETRONProficient Rx LP4feb4b89-2d2f-4a9c-a4f4-5ae3e26281b62022-04-01Warnings, Adverse reactionsExact identifier
rxcui: 312087
unii: 4AF302ESOS
ONDANSETRONONDANSETRONProficient Rx LP9913ed0c-aaad-45e1-b522-98ad170c2e8a2021-01-01Warnings, Adverse reactionsExact identifier
rxcui: 104894
unii: 4AF302ESOS
OndansetronONDANSETRONProficient Rx LPf1191e52-982e-49d1-946e-01b469ccedfe2020-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA090469
rxcui: 312087
unii: 4AF302ESOS

Reported adverse events (FAERS/openFDA)#

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