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 | Redpharm Drug | 541b9a0d-ae94-db6f-e063-6394a90a9805 | 2026-06-12 | Warnings, Adverse reactions | ANDA078539 198052 NMH84OZK2B |
| Ondansetron | ONDANSETRON | American Health Packaging | 92b96072-e8f2-4fd6-aaa0-b73fed214319 | 2026-06-01 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron | ONDANSETRON | Hospira, Inc. | d62cd60b-f87e-4825-bead-1d18bbc4e480 | 2026-05-23 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron | ONDANSETRON | Hospira, Inc. | 6a11f61b-2318-4382-2b91-4366e4bb53fa | 2026-05-22 | Warnings, Adverse reactions | NMH84OZK2B |
| ONDANSETRON | ONDANSETRON | A-S Medication Solutions | b60074e5-8e77-4dc0-9244-4205e4adbaef | 2026-05-11 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Sportpharm LLC | c0be25a0-e13d-4242-93dc-0b86e82aadd7 | 2026-04-24 | Warnings, Adverse reactions | ANDA078539 312086 NMH84OZK2B |
| Ondansetron | ONDANSETRON | Civica, Inc. | 70437694-0341-4f3b-824c-06843403443f | 2026-04-19 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron | ONDANSETRON | Hikma Pharmaceuticals USA Inc. | 97713356-f42b-4a67-95f6-561afa68c0c2 | 2026-04-16 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron | ONDANSETRON | Sportpharm LLC | 98c1413c-ff7f-4554-9e9f-289038b39ca6 | 2026-04-14 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | REMEDYREPACK INC. | 5cc67d95-6629-4451-9e34-2f7a60482be5 | 2026-04-10 | Warnings, Adverse reactions | ANDA078539 312086 NMH84OZK2B |
| Ondansetron | ONDANSETRON | Hikma Pharmaceuticals USA Inc. | c29ca6df-621d-44b6-98fc-b48666573366 | 2026-04-09 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Sportpharm LLC | b1324076-f83e-4816-9e02-6b2a689010bc | 2026-04-05 | Warnings, Adverse reactions | ANDA078539 198052 NMH84OZK2B |
| Ondansetron | ONDANSETRON | PAI Holdings, LLC dba PAI Pharma | 68a4d845-0c1c-4867-bfca-c0fb11dc93cd | 2026-03-31 | Warnings, Adverse reactions | NMH84OZK2B |
| ONDANSETRON | ONDANSETRON | HF Acquisition Co LLC, DBA HealthFirst | 4dcd1e4c-6a9c-7ac6-e063-6394a90a39bf | 2026-03-24 | Warnings, Adverse reactions | 198052 NMH84OZK2B |
| Ondansetron | ONDANSETRON | JVET PHARMACEUTICALS LLC | 95ca0d81-a0a8-441d-820e-cb6624018a15 | 2026-03-23 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron | ONDANSETRON | REMEDYREPACK INC. | 36592150-7e19-474c-9f96-cc8341e28b5d | 2026-03-20 | Warnings, Adverse reactions | 198052 NMH84OZK2B |
| Ondansetron HCL | ONDANSETRON HCL | Advanced Rx of Tennessee, LLC | af735f22-6d6c-6e1f-e053-2a95a90a3532 | 2026-03-13 | Warnings, Adverse reactions | ANDA078539 312086 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Bryant Ranch Prepack | e2c0e86c-e7fc-48f9-a894-02da8761001c | 2026-03-05 | Warnings, Adverse reactions | ANDA078539 198052 NMH84OZK2B |
| ONDANSETRON | ONDANSETRON | Direct_Rx | 90b73778-2ab5-5460-e053-2a95a90abbc1 | 2026-02-19 | Warnings, Adverse reactions | ANDA078539 198052 NMH84OZK2B |
| ONDANSETRON | ONDANSETRON | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | b746d4db-43e6-4219-9e6b-f53e59581305 | 2026-02-13 | Warnings, Adverse reactions | NMH84OZK2B |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.