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 | Atlantic Biologics Corp. | 41d71d26-0d42-b368-e063-6394a90add43 | 2025-10-23 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron | ONDANSETRON | Cardinal Health 107, LLC | 61758670-91ab-4422-8d9d-e8ca87eecae8 | 2025-10-23 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron | ONDANSETRON | Amneal Pharmaceuticals LLC | 38435346-d505-4bdd-bbc6-a7bcba411033 | 2025-09-23 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | PHOENIX RX LLC | 3a79fc2b-9ea3-a808-e063-6394a90ae794 | 2025-09-22 | Warnings, Adverse reactions | ANDA078539 198052 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | PHOENIX RX LLC | 40106070-6a25-5b0e-e063-6394a90a4197 | 2025-09-22 | Warnings, Adverse reactions | ANDA078539 198052 NMH84OZK2B |
| Ondansetron | ONDANSETRON | Fosun Pharma USA Inc. | e3f22b7e-b6ad-4799-93c7-d30540cada85 | 2025-09-19 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 0b675b09-fe40-435c-b91a-c61cdf767fbf | 2025-09-15 | Warnings, Adverse reactions | ANDA078539 312086 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 36d64400-2d13-4a1a-a1ca-4741cd3d3f1a | 2025-09-03 | Warnings, Adverse reactions | ANDA078539 198052 NMH84OZK2B |
| Ondansetron | ONDANSETRON | NorthStar Rx LLC | 9d5e7650-95be-4b96-b29c-374f673eb7a1 | 2025-09-03 | Warnings, Adverse reactions | ANDA078539 312086 198052 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Rising Pharma Holdings, Inc. | 90e0e508-75f7-4c8b-bb38-898aa4c531c3 | 2025-09-01 | Warnings, Adverse reactions | ANDA078539 312086 198052 NMH84OZK2B |
| ONDANSETRON | ONDANSETRON | ProPharma Distribution | 3d5d25eb-8711-ef8c-e063-6394a90a5e03 | 2025-08-27 | Warnings, Adverse reactions | NMH84OZK2B |
| ONDANSETRON | ONDANSETRON | Apotex Corp. | 2c68d202-fdf7-4b6a-dd7f-82624fcdbd4a | 2025-08-26 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 426ba54f-199a-41d1-8c27-f827bea56854 | 2025-08-15 | Warnings, Adverse reactions | ANDA078539 198052 NMH84OZK2B |
| Ondansetron | ONDANSETRON HYDROCHLORIDE | NorthStar Rx LLC | ac3dfb81-a4c7-4147-9374-c234153b7c51 | 2025-08-11 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron | ONDANSETRON | Gland Pharma Limited | 35716914-ac73-43c0-9aa0-09c99211d941 | 2025-07-31 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron | ONDANSETRON | Gland Pharma Limited | 3efa5604-96c3-42a0-8e99-b3de4a66aa92 | 2025-07-31 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | PHOENIX RX LLC | 3a76bae2-04c2-ee2d-e063-6394a90ad4c8 | 2025-07-21 | Warnings, Adverse reactions | ANDA078539 312086 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Aurobindo Pharma Limited | 57578387-1918-4e56-a564-f14fb22340bf | 2025-07-19 | Warnings, Adverse reactions | ANDA078539 65862-188 312086 198052 312084 8934ad79-3eda-46d1-b527-53d122760a89 57578387-1918-4e56-a564-f14fb22340bf NMH84OZK2B |
| Ondansetron | ONDANSETRON HYDROCHLORIDE | Aurobindo Pharma Limited | cf10d256-dd89-4a91-a3ed-81db505a79c2 | 2025-07-08 | Warnings, Adverse reactions | NMH84OZK2B |
| ONDANSETRON | ONDANSETRON HYDROCHLORIDE | Dr. Reddy's Laboratories Limited | 162f2088-9fb1-47e7-b88c-45104be7e7bb | 2025-06-30 | Warnings, Adverse reactions | 312086 198052 312084 NMH84OZK2B |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.