FDA.reportPublic FDA data

NDC 80425-0073-01 - Ondansetron ODT

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
80425-0073
Requested NDC
80425-0073-01
Package NDCs from labels
80425-0073-2, 80425-0073-1, 80425-0073-01
Manufacturer
Advanced Rx 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 ODT - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0073-1OndansetronODT20 in 1 BOTTLETABLET, ORALLY DISINTEGRATING207
80425-0073-2OndansetronODT30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0073ONDANSETRON ODT (ONDANSETRON) TABLET, ORALLY DISINTEGRATING [ADVANCED RX OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 2 package rows20250101_af836a30-5e51-5c97-e053-2995a90a15b9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0073-1EA - Each80425-00734040e0f1-940d-4692-a93c-10b9fcd7262512023-04-07
80425-0073-2EA - Each80425-007380e5f787-56ae-4b07-9dd7-6be6c7c0b75d12023-04-07

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 2 of 5 · 83 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OndansetronONDANSETRONBryant Ranch Prepack40258e4b-5e67-46c0-8ef0-3e8bfe36ba112026-04-16Warnings, Adverse reactionsExact identifier
rxcui: 312087
unii: 4AF302ESOS
OndansetronONDANSETRONNuCare Pharmaceuticals,Inc.5bacb621-1261-25d9-e053-2991aa0afa3b2026-04-08Warnings, Adverse reactionsExact identifier
rxcui: 104894
unii: 4AF302ESOS
ONDANSETRONONDANSETRONDirect Rxb38feff2-900a-4e0c-8260-8f090edbc0bc2026-03-17Warnings, Adverse reactionsExact identifier
application number: ANDA090469
rxcui: 312087
unii: 4AF302ESOS
OndansetronONDANSETRONNuCare Pharmaceuticals,Inc.df736abd-9cec-4e90-e053-2995a90aab5e2026-03-13Warnings, Adverse reactionsExact identifier
rxcui: 312087
unii: 4AF302ESOS
OndansetronONDANSETRONNuCare Pharmaceuticals, Inc.50383ef5-6e6e-63a7-e054-00144ff88e882026-03-04Warnings, Adverse reactionsExact identifier
rxcui: 104894
unii: 4AF302ESOS
OndansetronONDANSETRONNuCare Pharmaceuticals,Inc.ef6ce203-4ae3-19c9-e053-2995a90af7962026-02-27Warnings, Adverse reactionsExact identifier
rxcui: 104894
unii: 4AF302ESOS
OndansetronONDANSETRONA-S Medication Solutions378d0963-d026-4478-8202-fbb636904a372026-02-18Warnings, Adverse reactionsExact identifier
application number: ANDA090469
rxcui: 312087
rxcui: 104894
unii: 4AF302ESOS
OndansetronONDANSETRONNuCare Pharmaceuticals,Inc.9dff6676-e69e-779d-e053-2995a90a7c812026-01-27Warnings, Adverse reactionsExact identifier
application number: ANDA090469
rxcui: 312087
unii: 4AF302ESOS
OndansetronONDANSETRONNuCare Pharmaceuticals,Inc.76666e7e-3312-6f9d-e053-2991aa0af7052026-01-23Warnings, Adverse reactionsExact identifier
application number: ANDA090469
rxcui: 312087
unii: 4AF302ESOS
OndansetronONDANSETRONPD-Rx Pharmaceuticals, Inc.d117de5f-64e5-464c-b782-de0f07e66c8e2026-01-20Warnings, Adverse reactionsExact identifier
rxcui: 312087
unii: 4AF302ESOS
ondansetronONDANSETRONCardinal Health 107, LLC26aff90c-49ea-46ac-bbf3-c188c2b061c92026-01-14Warnings, Adverse reactionsExact identifier
rxcui: 104894
unii: 4AF302ESOS
OndansetronONDANSETRONGlenmark Pharmaceuticals Inc., USAeee5217a-eba8-463a-812d-bf3c66f0934f2026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 312087
rxcui: 104894
unii: 4AF302ESOS
OndansetronONDANSETRONNorthwind Health Company, LLCf2b502e2-03ed-fe5c-e053-2995a90a368e2026-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA090469
rxcui: 312087
unii: 4AF302ESOS
OndansetronONDANSETRONNorthwind Health Company, LLCdb9a0d22-9339-4319-e053-2a95a90a95922026-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA090469
rxcui: 104894
unii: 4AF302ESOS
OndansetronONDANSETRONNorthwind Health Company, LLCe07c38c0-e1c2-01de-e053-2995a90a390a2026-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA090469
rxcui: 312087
unii: 4AF302ESOS
OndansetronONDANSETRONNorthwind Health Company, LLCf29f5cfa-3cc4-7d53-e053-2995a90ae8442025-12-26Warnings, Adverse reactionsExact identifier
rxcui: 104894
unii: 4AF302ESOS
OndansetronONDANSETRONIpca Laboratories Limited8e24f935-87fe-4b6a-b265-60b1039f38d52025-12-22Warnings, Adverse reactionsExact identifier
rxcui: 312087
rxcui: 104894
unii: 4AF302ESOS
OndansetronONDANSETRONAvKARE352de988-d166-c2d8-e063-6294a90acc012025-11-17Warnings, Adverse reactionsExact identifier
rxcui: 312087
rxcui: 104894
unii: 4AF302ESOS
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
rxcui: 312087
rxcui: 104894
unii: 4AF302ESOS

Reported adverse events (FAERS/openFDA)#

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