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 8 of 12 · 221 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OndansetronONDANSETRONAsclemed USA, Inc.e436e361-da0f-7d6d-e053-2995a90a10e42025-02-21Warnings, Adverse reactionsExact identifier
rxcui: 312087
rxcui: 104894
unii: 4AF302ESOS
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDENuCare Pharmaceuticals,Inc.f8ada0e4-5c1b-17ab-e053-6294a90a12b82025-02-06Warnings, Adverse reactionsExact identifier
rxcui: 312086
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEAsclemed USA, Inc.65b0b2e2-37fd-4d08-9674-954d62bb531a2025-01-27Warnings, Adverse reactionsExact identifier
rxcui: 312086
rxcui: 198052
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDENuCare Pharmaceuticals,Inc.b43e15d6-b778-7575-e053-2995a90a93a02025-01-14Warnings, Adverse reactionsExact identifier
rxcui: 198052
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEAvPAKe4766235-ac44-ca93-78a6-66d4ded33ada2025-01-09Warnings, Adverse reactionsExact identifier
rxcui: 312086
rxcui: 198052
unii: NMH84OZK2B
ONDANSETRONONDANSETRONHF Acquisition Co LLC, DBA HealthFirst7b062fa9-e004-23d5-e053-2a91aa0a20cd2025-01-08Warnings, Adverse reactionsExact identifier
rxcui: 104894
unii: 4AF302ESOS
ONDANSETRONONDANSETRONHF Acquisition Co LLC, DBA HealthFirst99ac0a5e-dd2a-4352-e053-2a95a90a68fd2025-01-08Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Ondansetron ODTONDANSETRONAdvanced Rx of Tennessee, LLCaf836a30-5e51-5c97-e053-2995a90a15b92024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 104894
unii: 4AF302ESOS
Ondansetron HCLONDANSETRON HCLAdvanced Rx of Tennessee, LLCaf75407e-82aa-136f-e053-2995a90a429b2024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 312086
unii: NMH84OZK2B
Ondansetron HCLONDANSETRON HCLAdvanced Rx of Tennessee, LLCaf830edc-ce9e-b038-e053-2a95a90ae9742024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 198052
unii: NMH84OZK2B
OndansetronONDANSETRONAdvanced Rx Pharmacy of Tennessee, LLCf1a0ea2c-0788-4e8a-e053-2a95a90a2f322024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA078152
rxcui: 312087
unii: 4AF302ESOS
OndansetronONDANSETRONAdvanced Rx Pharmacy of Tennessee, LLCf1a0cd50-aa4f-55bc-e053-2995a90a2d3a2024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA078152
ndc (package): 80425-0227-1
ndc (product): 80425-0227
ndc11 (package): 80425022701
rxcui: 312087
spl id: 2a9aec09-6306-2252-e063-6294a90a204a
spl set id: f1a0cd50-aa4f-55bc-e053-2995a90a2d3a
unii: 4AF302ESOS
OndansetronONDANSETRONNuCare Pharmaceuticals,Inc.e183c59c-2a7c-dba3-e053-2a95a90acf872024-12-30Warnings, Adverse reactionsExact identifier
rxcui: 312087
unii: 4AF302ESOS
OndansetronONDANSETRONAdvanced Rx of Tennessee, LLC2a8603a9-5b6f-b921-e063-6394a90ae29c2024-12-29Warnings, Adverse reactionsExact identifier
application number: ANDA078152
rxcui: 104894
unii: 4AF302ESOS
OndansetronONDANSETRONAdvanced Rx of Tennessee, LLC2a863485-a0a8-db63-e063-6294a90ab6052024-12-29Warnings, Adverse reactionsExact identifier
rxcui: 104894
unii: 4AF302ESOS
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEQuality Care Products, LLC2e0b1b09-9e68-4728-82d5-1f86510a0f2a2024-12-19Warnings, Adverse reactionsExact identifier
rxcui: 198052
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEQuality Care Products LLC54e8981e-6880-4d4f-bc46-600c2af596982024-12-18Warnings, Adverse reactionsExact identifier
rxcui: 312086
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEQuality Care Products LLC89091629-d15e-4e95-aed8-8bc983c783022024-12-18Warnings, Adverse reactionsExact identifier
rxcui: 198052
unii: NMH84OZK2B
OndansetronONDANSETRONNuCare Pharmaceuticals, Inc.2553816f-161e-ac86-e063-6394a90aad6d2024-10-25Warnings, Adverse reactionsExact identifier
rxcui: 312086
unii: NMH84OZK2B
OndansetronONDANSETRONBryant Ranch Prepackf08f56de-8678-4da9-8cae-013a5c3934532024-10-02Warnings, Adverse reactionsExact identifier
rxcui: 198052
unii: NMH84OZK2B

Reported adverse events (FAERS/openFDA)#

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