FDA.reportPublic FDA data

NDC 80425-0075-01 - Ondansetron HCL

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
80425-0075
Requested NDC
80425-0075-01
Package NDCs from labels
80425-0075-4, 80425-0075-1, 80425-0075-3, 80425-0075-2, 80425-0075-5, 80425-0075-01
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 HCL - 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
80425-0075-1Ondansetron HCL10 in 1 BOTTLETABLET, FILM COATED109
80425-0075-2Ondansetron HCL15 in 1 BOTTLETABLET, FILM COATED159
80425-0075-3Ondansetron HCL20 in 1 BOTTLETABLET, FILM COATED209
80425-0075-4Ondansetron HCL30 in 1 BOTTLETABLET, FILM COATED309
80425-0075-5Ondansetron HCL60 in 1 BOTTLETABLET, FILM COATED609

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0075ONDANSETRON HCL TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]9Current NDC, Legacy NDC, 5 package rows20250101_af75407e-82aa-136f-e053-2995a90a429b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0075-1EA - Each80425-00750d0bf3c7-ecec-4e5d-9648-fe3bc130229c12023-04-07
80425-0075-2EA - Each80425-0075da9ba779-c847-498f-b0e2-d41b38c6f42212023-04-07
80425-0075-3EA - Each80425-007542e002ba-d6b6-4b43-9f7a-74504858ae6212023-04-07
80425-0075-4EA - Each80425-007501faaa8b-e11c-4f99-a5b1-e1a96632922712023-04-07
80425-0075-5EA - Each80425-007518f85afa-0251-4fc9-b432-7a0b0553a58712023-04-07

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 8 · 141 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDEBaxter Healthcare Corporation729d865f-d84a-495e-9456-4bceebb6e03f2025-06-30Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
OndansetronONDANSETRONCardinal Health 107, LLCee1f115f-c8f8-4526-b827-c8e48aeb50502025-06-20Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
ondansetron hydrochlorideONDANSETRON HYDROCHLORIDESun Pharmaceutical Industries, Inc.92c758a3-e749-4a15-be4b-ee30b364b2b02025-06-12Warnings, Adverse reactionsExact identifier
rxcui: 312086
rxcui: 198052
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEHikma Pharmaceuticals USA Inc.1a0c4dc6-643e-4ee7-92a9-edb98049a5ba2025-06-09Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
ONDANSETRONONDANSETRONBryant Ranch Prepack384a5cfb-05dd-2b79-73f4-a01a47a9eb3e2025-06-02Warnings, Adverse reactionsExact identifier
rxcui: 198052
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEPrecision Dose Inc.04800a86-2391-44e6-8763-d65e8a916c262025-05-30Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
OndansetronONDANSETRONATLANTIC BIOLOGICALS CORP.e5ab38a2-5921-4320-a313-e0080c0780462025-05-28Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
OndansetronONDANSETRONNuCare Pharmaceuticals, Inc.2eeb3c61-4ce9-d8ed-e063-6294a90a00d32025-02-24Warnings, Adverse reactionsExact identifier
application number: ANDA078539
rxcui: 312086
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDENuCare Pharmaceuticals,Inc.f8ada0e4-5c1b-17ab-e053-6294a90a12b82025-02-06Warnings, Adverse reactionsExact identifier
application number: ANDA078539
rxcui: 312086
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEAsclemed USA, Inc.65b0b2e2-37fd-4d08-9674-954d62bb531a2025-01-27Warnings, Adverse reactionsExact identifier
application number: ANDA078539
rxcui: 312086
rxcui: 198052
rxcui: 312084
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDENuCare Pharmaceuticals,Inc.b43e15d6-b778-7575-e053-2995a90a93a02025-01-14Warnings, Adverse reactionsExact identifier
application number: ANDA078539
rxcui: 198052
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEAvPAKe4766235-ac44-ca93-78a6-66d4ded33ada2025-01-09Warnings, Adverse reactionsExact identifier
application number: ANDA078539
rxcui: 312086
rxcui: 198052
unii: NMH84OZK2B
ONDANSETRONONDANSETRONHF Acquisition Co LLC, DBA HealthFirst99ac0a5e-dd2a-4352-e053-2a95a90a68fd2025-01-08Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Ondansetron HCLONDANSETRON HCLAdvanced Rx of Tennessee, LLCaf75407e-82aa-136f-e053-2995a90a429b2024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA078539
ndc (package): 80425-0075-5
ndc (package): 80425-0075-2
ndc (package): 80425-0075-1
ndc (package): 80425-0075-4
ndc (package): 80425-0075-3
ndc (product): 80425-0075
ndc11 (package): 80425007501
rxcui: 312086
spl id: 2a98ff70-0366-7169-e063-6394a90adc74
spl set id: af75407e-82aa-136f-e053-2995a90a429b
unii: NMH84OZK2B
Ondansetron HCLONDANSETRON HCLAdvanced Rx of Tennessee, LLCaf830edc-ce9e-b038-e053-2a95a90ae9742024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA078539
rxcui: 198052
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEQuality Care Products, LLC2e0b1b09-9e68-4728-82d5-1f86510a0f2a2024-12-19Warnings, Adverse reactionsExact identifier
application number: ANDA078539
rxcui: 198052
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEQuality Care Products LLC54e8981e-6880-4d4f-bc46-600c2af596982024-12-18Warnings, Adverse reactionsExact identifier
application number: ANDA078539
rxcui: 312086
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEQuality Care Products LLC89091629-d15e-4e95-aed8-8bc983c783022024-12-18Warnings, Adverse reactionsExact identifier
application number: ANDA078539
rxcui: 198052
unii: NMH84OZK2B
OndansetronONDANSETRONNuCare Pharmaceuticals, Inc.2553816f-161e-ac86-e063-6394a90aad6d2024-10-25Warnings, Adverse reactionsExact identifier
application number: ANDA078539
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.