NDC 80425-0074-03 - 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
- 80425-0074
- Requested NDC
- 80425-0074-03
- Package NDCs from labels
- 80425-0074-4, 80425-0074-1, 80425-0074-2, 80425-0074-3, 80425-0074-5, 80425-0074-6, 80425-0074-03
- Manufacturer
- Advanced Rx of Tennessee, LLC
- Effective date
- 2026-03-13
- 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 | 2026-03-13 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0074-1 | Ondansetron HCL | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | 10 | |
| 80425-0074-2 | Ondansetron HCL | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | 10 | |
| 80425-0074-3 | Ondansetron HCL | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | 10 | |
| 80425-0074-4 | Ondansetron HCL | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 10 | |
| 80425-0074-5 | Ondansetron HCL | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 10 | |
| 80425-0074-6 | Ondansetron HCL | 9 in 1 BOTTLE | TABLET, FILM COATED | 9 | 10 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0074 | ONDANSETRON HCL TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC] | 9 | Current NDC, Legacy NDC, 6 package rows | 20250101_af735f22-6d6c-6e1f-e053-2a95a90a3532.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0074-1 | EA - Each | 80425-0074 | b8259352-ca33-4634-baa0-fd23aa4a0f5f | 1 | 2023-04-07 |
| 80425-0074-2 | EA - Each | 80425-0074 | d7468810-9f71-4f89-9142-1e512e6591d7 | 1 | 2023-04-07 |
| 80425-0074-3 | EA - Each | 80425-0074 | 66cc52d3-1154-4cf8-865c-458cb36854d5 | 1 | 2023-04-07 |
| 80425-0074-4 | EA - Each | 80425-0074 | 1aef171c-97dc-4cb9-b81f-9b4148fe031b | 1 | 2023-04-07 |
| 80425-0074-5 | EA - Each | 80425-0074 | c7154753-8173-4630-924d-770c2eeb4564 | 1 | 2023-04-07 |
| 80425-0074-6 | EA - Each | 80425-0074 | 101f4a83-24f6-40e1-8d3b-317cd74b99fa | 1 | 2026-04-20 |
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 | REMEDYREPACK INC. | 960e2104-18c3-4cfa-abf6-f1b30c452918 | 2026-09-08 | Warnings, Adverse reactions | ANDA078539 198052 NMH84OZK2B |
| Ondansetron | ONDANSETRON | REMEDYREPACK INC. | 416be720-82e8-4a6d-8531-c1a29869daae | 2026-09-01 | Warnings, Adverse reactions | ANDA078539 312086 NMH84OZK2B |
| ondansetron | ONDANSETRON HYDROCHLORIDE | Major Pharmaceuticals | a29b5c18-9884-4c88-8827-65d9ad5f69f6 | 2026-08-21 | Warnings, Adverse reactions | 312086 198052 NMH84OZK2B |
| ondansetron | ONDANSETRON HYDROCHLORIDE | Bryant Ranch Prepack | 37de0550-a6d1-46a8-a0b8-447b0dcf70ad | 2026-08-19 | Warnings, Adverse reactions | 312086 198052 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Unit Dose Solutions, Inc. | 5566aebb-d84d-6d6a-e063-6294a90a746f | 2026-08-18 | Warnings, Adverse reactions | ANDA078539 198052 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 2a30d534-4607-4882-865e-56d2364acaad | 2026-08-07 | Warnings, Adverse reactions | ANDA078539 312086 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | 14276805-4e99-4bbe-ad76-ffc06eddb38a | 2026-08-06 | Warnings, Adverse reactions | ANDA078539 312086 198052 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 00b17a8e-9d38-a8d4-e063-6294a90a153e | 2026-08-05 | Warnings, Adverse reactions | ANDA078539 312086 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Proficient Rx LP | 0a14eb9a-0385-40e9-a7ec-71435450ac91 | 2026-08-01 | Warnings, Adverse reactions | ANDA078539 198052 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 57b0a1e5-5dfa-64a0-e063-6394a90acf36 | 2026-07-24 | Warnings, Adverse reactions | ANDA078539 198052 NMH84OZK2B |
| ONDANSETRON | ONDANSETRON | Henry Schein, Inc. | 1a44601b-c31c-4779-a688-28cc4cc75e8b | 2026-07-23 | Warnings, Adverse reactions | NMH84OZK2B |
| ondansetron hydrochloride | ONDANSETRON HYDROCHLORIDE | Ipca Laboratories Limited | 7ab3210e-eed1-479a-afc0-f72b5b776883 | 2026-07-22 | Warnings, Adverse reactions | 312086 198052 NMH84OZK2B |
| ondansetron | ONDANSETRON HYDROCHLORIDE | Ascend Laboratories, LLC | 2edc0788-dc38-4d21-ba8e-71f159e2d3b1 | 2026-07-22 | Warnings, Adverse reactions | 312086 198052 NMH84OZK2B |
| ondansetron | ONDANSETRON HYDROCHLORIDE | Cardinal Health 107, LLC | cb02f2d7-31a9-4f12-880e-7ce7d85440d4 | 2026-07-17 | Warnings, Adverse reactions | 312086 198052 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Bryant Ranch Prepack | 3f2e8efe-7fd4-407c-a77b-bd6dd04608e2 | 2026-07-10 | Warnings, Adverse reactions | ANDA078539 198052 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | REMEDYREPACK INC. | ee3e8cbe-4f0b-4361-a1b5-8329d85a2932 | 2026-07-08 | Warnings, Adverse reactions | ANDA078539 198052 NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | Unit Dose Solutions, Inc. | 561dce26-92fa-e00b-e063-6294a90a1ab2 | 2026-07-08 | Warnings, Adverse reactions | ANDA078539 198052 NMH84OZK2B |
| ONDANSETRON | ONDANSETRON | Sportpharm LLC | de72f1ec-75dd-4659-a1a0-32b28b72c799 | 2026-07-02 | Warnings, Adverse reactions | NMH84OZK2B |
| Ondansetron Hydrochloride | ONDANSETRON HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 58f16a00-3e66-29de-e053-2991aa0a59a0 | 2026-06-26 | Warnings, Adverse reactions | ANDA078539 198052 NMH84OZK2B |
| Ondansetron | ONDANSETRON | Cardinal Health 107, LLC | 1b9c2d9f-62a8-4d26-a041-a598bc59e300 | 2026-06-26 | Warnings, Adverse reactions | NMH84OZK2B |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.