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
Label	Manufacturer	Effective date	Type
Ondansetron ODT - Advanced Rx of Tennessee, LLC	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80425-0073-1	OndansetronODT	20 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	20		7
80425-0073-2	OndansetronODT	30 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	30		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0073	ONDANSETRON ODT (ONDANSETRON) TABLET, ORALLY DISINTEGRATING [ADVANCED RX OF TENNESSEE, LLC]	7	Current NDC, Legacy NDC, 2 package rows	20250101_af836a30-5e51-5c97-e053-2995a90a15b9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0073-1	EA - Each	80425-0073	4040e0f1-940d-4692-a93c-10b9fcd72625	1	2023-04-07
80425-0073-2	EA - Each	80425-0073	80e5f787-56ae-4b07-9dd7-6be6c7c0b75d	1	2023-04-07

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 5 of 5 · 83 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ONDANSETRON	ONDANSETRON	Proficient Rx LP	4feb4b89-2d2f-4a9c-a4f4-5ae3e26281b6	2022-04-01	Warnings, Adverse reactions	Exact identifier rxcui: 312087 unii: 4AF302ESOS
ONDANSETRON	ONDANSETRON	Proficient Rx LP	9913ed0c-aaad-45e1-b522-98ad170c2e8a	2021-01-01	Warnings, Adverse reactions	Exact identifier rxcui: 104894 unii: 4AF302ESOS
Ondansetron	ONDANSETRON	Proficient Rx LP	f1191e52-982e-49d1-946e-01b469ccedfe	2020-01-01	Warnings, Adverse reactions	Exact identifier application number: ANDA090469 rxcui: 312087 unii: 4AF302ESOS

Reported adverse events (FAERS/openFDA)#

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