NDC 80425-0313-01 - Fluoxetine
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
- 80425-0313
- Requested NDC
- 80425-0313-01
- Package NDCs from labels
- 80425-0313-1, 80425-0313-2, 80425-0313-3, 80425-0313-01
- Manufacturer
- Advanced Rx Pharmacy 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 |
|---|---|---|---|
| Fluoxetine - Advanced Rx Pharmacy of Tennessee, LLC | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0313-1 | Fluoxetine | 30 in 1 BOTTLE | CAPSULE | 30 | 2 | |
| 80425-0313-2 | Fluoxetine | 60 in 1 BOTTLE | CAPSULE | 60 | 2 | |
| 80425-0313-3 | Fluoxetine | 90 in 1 BOTTLE | CAPSULE | 90 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0313 | FLUOXETINE CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 2 | Current NDC, 3 package rows | 20250102_f917063a-226e-0978-e053-6294a90aeb4b.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0313-1 | EA - Each | 80425-0313 | b8d1d31a-fff6-4b9c-a9b3-e011b8c7eb47 | 1 | 2023-06-06 |
| 80425-0313-2 | EA - Each | 80425-0313 | 829bc627-e21e-4aa1-99b3-4b8ba39cdb6f | 1 | 2023-06-06 |
| 80425-0313-3 | EA - Each | 80425-0313 | 562d5109-ba29-492b-84e6-90b21d9adfc7 | 1 | 2023-06-06 |
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 |
|---|---|---|---|---|---|---|
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 023cef65-c9c2-4d70-af66-198fb1b57714 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | ANDA204597 313989 I9W7N6B1KJ |
| Fluoxetine HCL | FLUOXETINE HCL | Direct_rx | 48705e4f-c3ee-af78-e063-6394a90ad052 | 2026-06-17 | Boxed warning, Warnings, Adverse reactions | ANDA204597 310385 I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE | QPharma Inc | 50253c6e-de36-05e6-e063-6294a90ad7a8 | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | 310385 I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Coupler LLC | 5386a140-7c5b-5959-e063-6294a90a2ad0 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | ANDA204597 313989 I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 992060ee-fb4e-4c6d-9ffe-30902bc63af2 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | 313989 I9W7N6B1KJ |
| fluoxetine hydrochloride | FLUOXETINE HYDROCHLORIDE | Par Health USA, LLC | 53ac797d-8792-4a8c-9708-d1de3d377e8f | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | a9de93d4-2edc-2838-e053-2995a90a8ed6 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | ANDA204597 310385 I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE | PD-Rx Pharmaceuticals, Inc. | 5dc20c8f-0d8f-400c-b850-fe1b7e3e75e3 | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | 313989 I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE | PD-Rx Pharmaceuticals, Inc. | 51b8e791-4e9a-4014-b4d8-68fd51ca889f | 2026-05-04 | Boxed warning, Warnings, Adverse reactions | 310384 I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE | Proficient Rx LP | 1a2a5194-b793-4c62-a177-040dad38526b | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | 310384 I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 7d7a196b-91de-4753-8bb6-c6d5c668952d | 2026-04-29 | Boxed warning, Warnings, Adverse reactions | 310384 I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Coupler LLC | 5020d0d6-969e-b4cd-e063-6294a90af9d2 | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | ANDA204597 310384 I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE | REMEDYREPACK INC. | d1c768b5-64bb-4036-aa92-797b3a5f92eb | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | 310384 I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE | Coupler LLC | 50117d4f-0777-54d3-e063-6394a90a857c | 2026-04-22 | Boxed warning, Warnings, Adverse reactions | 310385 I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE | Northwind Health Company, LLC | 50369762-c7c3-d58e-e063-6294a90af8df | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | 310384 I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ef0fa849-a3a0-45d2-9258-da2d46bee089 | 2026-04-17 | Boxed warning, Warnings, Adverse reactions | ANDA204597 310384 I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ec608267-9c00-4d5c-a9ed-d89503f93d28 | 2026-04-17 | Boxed warning, Warnings, Adverse reactions | ANDA204597 313989 I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | e83e2220-d32a-472c-bd9f-b87d0cf8858f | 2026-04-17 | Boxed warning, Warnings, Adverse reactions | ANDA204597 310385 I9W7N6B1KJ |
| FLUOXETINE | FLUOXETINE | Preferred Pharmaceuticals Inc. | 54ded68c-1d2e-453d-b155-84c3102e1f0e | 2026-04-17 | Boxed warning, Warnings, Adverse reactions | 313989 I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE | A-S Medication Solutions | 679e439a-d955-4b54-8236-a2ccd9a2a10a | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | 310385 I9W7N6B1KJ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.