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 | Type |
|---|---|---|---|
| Ondansetron HCL - Advanced Rx of Tennessee, LLC | Advanced Rx of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0075-1 | Ondansetron HCL | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | 9 | |
| 80425-0075-2 | Ondansetron HCL | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | 9 | |
| 80425-0075-3 | Ondansetron HCL | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | 9 | |
| 80425-0075-4 | Ondansetron HCL | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 9 | |
| 80425-0075-5 | Ondansetron HCL | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 9 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0075 | ONDANSETRON HCL TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC] | 9 | Current NDC, Legacy NDC, 5 package rows | 20250101_af75407e-82aa-136f-e053-2995a90a429b.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0075-1 | EA - Each | 80425-0075 | 0d0bf3c7-ecec-4e5d-9648-fe3bc130229c | 1 | 2023-04-07 |
| 80425-0075-2 | EA - Each | 80425-0075 | da9ba779-c847-498f-b0e2-d41b38c6f422 | 1 | 2023-04-07 |
| 80425-0075-3 | EA - Each | 80425-0075 | 42e002ba-d6b6-4b43-9f7a-74504858ae62 | 1 | 2023-04-07 |
| 80425-0075-4 | EA - Each | 80425-0075 | 01faaa8b-e11c-4f99-a5b1-e1a966329227 | 1 | 2023-04-07 |
| 80425-0075-5 | EA - Each | 80425-0075 | 18f85afa-0251-4fc9-b432-7a0b0553a587 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Bryant Ranch Prepack | 8585e68b-965f-4f95-a5df-eea023cd5f82 | 2024-08-21 | Warnings, Adverse reactions | ANDA078539 198052 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Bryant Ranch Prepack | 3aeb533a-e72c-4af8-9867-b71d2eba9a49 | 2024-08-20 | Warnings, Adverse reactions | ANDA078539 198052 NMH84OZK2B |
| ondansetron | ONDANSETRON HYDROCHLORIDE | Sagent Pharmaceuticals | ba0f8f13-1f7d-44e0-9c0f-0b43a9e8e3a7 | 2024-08-15 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Bryant Ranch Prepack | 115e8fb5-61f5-4719-8eb3-063b7ca194ae | 2024-08-08 | Warnings, Adverse reactions | ANDA078539 312086 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Bryant Ranch Prepack | d6694136-7591-4f23-8415-f2aa3c8bab40 | 2024-07-16 | Warnings, Adverse reactions | ANDA078539 312086 NMH84OZK2B |
| ONDANSETRON | ONDANSETRON | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 8cea2f3a-cfa5-4a68-9ff4-b5a5a2085d08 | 2024-06-25 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron | ONDANSETRON HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 1b406d22-f1bf-460d-e063-6294a90a6b6f | 2024-06-19 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 91bfbc0e-86a3-8ac6-e053-2a95a90af432 | 2024-06-19 | Warnings, Adverse reactions | ANDA078539 198052 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | NUCARE PHARMACEUTICALS INC | 8d696b8c-eba6-505e-e053-2995a90acb5d | 2024-06-18 | Warnings, Adverse reactions | ANDA078539 312086 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 7f315229-7e8f-67fd-e053-2a91aa0a8cb6 | 2024-06-12 | Warnings, Adverse reactions | ANDA078539 312086 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | NuCare Pharmceuticals,Inc. | 67395789-0ac7-2244-e053-2a91aa0a652a | 2024-06-07 | Warnings, Adverse reactions | ANDA078539 312086 NMH84OZK2B |
| ondansetron hydrochloride | ONDANSETRON HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 00327696-c496-4c83-a63e-9e29fd6246d4 | 2024-04-24 | Warnings, Adverse reactions | 198052 NMH84OZK2B |
| ONDANSETRON | ONDANSETRON | HF Acquisition Co LLC, DBA HealthFirst | a62e2a6a-6235-7580-e053-2a95a90aa2b0 | 2024-02-26 | Warnings, Adverse reactions | NMH84OZK2B |
| ONDANSETRON | ONDANSETRON | HF Acquisition Co LLC, DBA HealthFirst | 768aa02b-8231-5799-e053-2a91aa0a618d | 2024-02-22 | Warnings, Adverse reactions | NMH84OZK2B |
| ONDANSETRON | ONDANSETRON | HF Acquisition Co LLC, DBA HealthFirst | cdb2c4b4-a20a-3f8f-e053-2a95a90aaf72 | 2024-01-30 | Warnings, Adverse reactions | 198052 NMH84OZK2B |
| Ondansetron | ONDANSETRON HYDROCHLORIDE | Eugia US LLC | 1cc94c7a-617c-4238-8248-e3fabc9612c7 | 2024-01-02 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron | ONDANSETRON HYDROCHLORIDE | Fresenius Kabi USA, LLC | 6a231919-6837-4b09-b66d-3706432b9702 | 2023-11-20 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron | ONDANSETRON HYDROCHLORIDE | Fresenius Kabi USA, LLC | e0050959-c14c-41b6-9a92-fadc5f6feff3 | 2023-11-02 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | A-S Medication Solutions | 674ea285-8f84-4603-9655-82200c523fe5 | 2023-10-25 | Warnings, Adverse reactions | ANDA078539 312086 198052 NMH84OZK2B |
| ONDANSETRON | ONDANSETRON | Chartwell RX, LLC | 88b7432b-f5a7-40f3-9b0c-e7b125f5103c | 2023-10-05 | Warnings, Adverse reactions | 312086 198052 NMH84OZK2B |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.