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 | ONDANSETRON HYDROCHLORIDE | Fresenius Kabi USA, LLC | d89017aa-b8c3-4fd2-8e68-44e2cfd6f290 | 2023-08-16 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Proficient Rx LP | 65f01335-452e-42c6-a59b-4eb03badc55a | 2023-06-01 | Warnings, Adverse reactions | ANDA078539 312086 NMH84OZK2B |
| Ondansetron | ONDANSETRON | Medical Purchasing Solutions, LLC | 79756604-56e6-d0ef-e053-2991aa0adc99 | 2023-05-23 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron | ONDANSETRON | Medical Purchasing Solutions, LLC | 70bf93bc-e979-f080-e053-2991aa0a21df | 2023-05-16 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron | ONDANSETRON | Medical Purchasing Solutions, LLC | 89698ef8-62d3-77e4-e053-2995a90ab9db | 2023-05-15 | Warnings, Adverse reactions | NMH84OZK2B |
| ONDANSETRON | ONDANSETRON | Medical Purchasing Solutions, LLC | 677b5fc5-9471-638b-e053-2991aa0a7f97 | 2023-04-26 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | A-S Medication Solutions | f8f371c7-09f8-426c-ae22-753cd5626da3 | 2023-01-23 | Warnings, Adverse reactions | ANDA078539 198052 NMH84OZK2B |
| Sumansetron | SUMATRIPTAN SUCCINATE, ONDANSETRON | PureTek Corporation | b69f0762-a2f7-28c7-e053-2995a90a0484 | 2023-01-11 | Warnings, Adverse reactions | 198052 |
| ONDANSETRON | ONDANSETRON | HF Acquisition Co LLC, DBA HealthFirst | 993cd1d7-70a1-a431-e053-2a95a90a5771 | 2022-12-10 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron | ONDANSETRON | PharmPak, Inc. | 8e289184-6046-4b55-97d2-cb276d5782d5 | 2022-10-09 | Warnings, Adverse reactions | ANDA078539 198052 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Pharmpak, Inc. | e41b9469-e844-47d9-933a-4c9f4453ecc7 | 2022-10-09 | Warnings, Adverse reactions | ANDA078539 312086 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Proficient Rx LP | 69ed01b7-a94e-4946-a044-a9f8c37616ec | 2022-05-02 | Warnings, Adverse reactions | ANDA078539 312086 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Proficient Rx LP | 381b44e7-a5a1-42ad-bcea-1ab4c82ff5d4 | 2022-04-01 | Warnings, Adverse reactions | ANDA078539 198052 NMH84OZK2B |
| ONDANSETRON | ONDANSETRON | Qilu Pharmaceutical Co., Ltd. | 5e09e262-dadf-4ae0-825e-448ea8dac174 | 2022-03-02 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron | ONDANSETRON TABLETS | Natco Pharma Limited | 59c817b7-a1c6-48a5-9bfc-2c381532bfd9 | 2021-11-29 | Warnings, Adverse reactions | 312086 198052 NMH84OZK2B |
| ondansetron hydrochloride | ONDANSETRON HYDROCHLORIDE | Dr. Reddy's Laboratories Limited | 476e704c-95ae-4591-94f7-ee4ab827ff13 | 2021-05-25 | Warnings, Adverse reactions | NMH84OZK2B |
| ondansetron | ONDANSETRON HYDROCHLORIDE | Proficient Rx LP | bde7c22c-0047-4735-8df6-b48e8dfa478a | 2021-01-01 | Warnings, Adverse reactions | 312086 NMH84OZK2B |
| ONDANSETRON | ONDANSETRON | Proficient Rx LP | 41c0dc3d-a616-425e-9073-625a0cb692c4 | 2019-11-01 | Warnings, Adverse reactions | 312086 198052 NMH84OZK2B |
| ONDANSETRON | ONDANSETRON | Sun Pharmaceutical Industries, Inc. | 834bc56a-657d-4733-9a60-47040cb5c7bf | 2019-09-11 | Warnings, Adverse reactions | 312086 198052 NMH84OZK2B |
| Ondansetron | ONDANSETRON | West-Ward Pharmaceuticals Corp | bb4bc810-db26-471b-9ce7-6e2fb3018af0 | 2018-12-14 | Warnings, Adverse reactions | NMH84OZK2B |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.