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 4 of 12 · 221 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ondansetron HCLONDANSETRON HCLAdvanced Rx of Tennessee, LLCaf735f22-6d6c-6e1f-e053-2a95a90a35322026-03-13Warnings, Adverse reactionsExact identifier
rxcui: 312086
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEBryant Ranch Prepacke2c0e86c-e7fc-48f9-a894-02da8761001c2026-03-05Warnings, Adverse reactionsExact identifier
rxcui: 198052
unii: NMH84OZK2B
OndansetronONDANSETRONNuCare Pharmaceuticals, Inc.50383ef5-6e6e-63a7-e054-00144ff88e882026-03-04Warnings, Adverse reactionsExact identifier
application number: ANDA078152
rxcui: 104894
unii: 4AF302ESOS
OndansetronONDANSETRONNuCare Pharmaceuticals,Inc.ef6ce203-4ae3-19c9-e053-2995a90af7962026-02-27Warnings, Adverse reactionsExact identifier
application number: ANDA078152
rxcui: 104894
unii: 4AF302ESOS
ONDANSETRONONDANSETRONDirect_Rx90b73778-2ab5-5460-e053-2a95a90abbc12026-02-19Warnings, Adverse reactionsExact identifier
rxcui: 198052
unii: NMH84OZK2B
OndansetronONDANSETRONA-S Medication Solutions378d0963-d026-4478-8202-fbb636904a372026-02-18Warnings, Adverse reactionsExact identifier
rxcui: 312087
rxcui: 104894
unii: 4AF302ESOS
ONDANSETRONONDANSETRONHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.b746d4db-43e6-4219-9e6b-f53e595813052026-02-13Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEA-S Medication Solutionse0f69f57-aeb9-4890-85aa-e5976208e8be2026-02-12Warnings, Adverse reactionsExact identifier
rxcui: 312086
unii: NMH84OZK2B
OndansetronONDANSETRONNuCare Pharmaceuticals,Inc.9dff6676-e69e-779d-e053-2995a90a7c812026-01-27Warnings, Adverse reactionsExact identifier
rxcui: 312087
unii: 4AF302ESOS
OndansetronONDANSETRONGolden State Medical Supply, Inc.2b9ea1fc-59a4-8189-e063-6394a90a9ae62026-01-27Warnings, Adverse reactionsExact identifier
rxcui: 312086
rxcui: 198052
unii: NMH84OZK2B
OndansetronONDANSETRONNuCare Pharmaceuticals,Inc.76666e7e-3312-6f9d-e053-2991aa0af7052026-01-23Warnings, Adverse reactionsExact identifier
rxcui: 312087
unii: 4AF302ESOS
OndansetronONDANSETRONPD-Rx Pharmaceuticals, Inc.15d0a711-ef3b-4d93-8fbc-17a45f96af8a2026-01-20Warnings, Adverse reactionsExact identifier
rxcui: 312086
unii: NMH84OZK2B
OndansetronONDANSETRONPD-Rx Pharmaceuticals, Inc.d117de5f-64e5-464c-b782-de0f07e66c8e2026-01-20Warnings, Adverse reactionsExact identifier
application number: ANDA078152
rxcui: 312087
unii: 4AF302ESOS
ondansetronONDANSETRONCardinal Health 107, LLC26aff90c-49ea-46ac-bbf3-c188c2b061c92026-01-14Warnings, Adverse reactionsExact identifier
rxcui: 104894
unii: 4AF302ESOS
ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDECardinal Health 107, LLC30107d6f-5128-484f-b713-65244a98dc672026-01-14Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
OndansetronONDANSETRONAvPAK05cf8d4f-ac57-4177-e063-6394a90ae8042026-01-09Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
OndansetronONDANSETRONGlenmark Pharmaceuticals Inc., USAeee5217a-eba8-463a-812d-bf3c66f0934f2026-01-08Warnings, Adverse reactionsExact identifier
application number: ANDA078152
ndc (product): 68462-158
rxcui: 312086
rxcui: 198052
rxcui: 312087
rxcui: 104894
spl id: 32177a6a-8c35-4e1c-b7f5-7376b1c1316a
spl set id: eee5217a-eba8-463a-812d-bf3c66f0934f
unii: 4AF302ESOS
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEChartwell Governmental & Specialty RX, LLC.7e862601-1d8a-455b-8ce5-1a32478b309f2026-01-07Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEChartwell RX, LLC.2086bae8-7c3c-4663-93ac-c86407c524c22026-01-02Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDENorthwind Health Company, LLCf76d27c5-acd4-482c-e053-6294a90a52842026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 198052
unii: NMH84OZK2B

Reported adverse events (FAERS/openFDA)#

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