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 | NorthStar Rx LLC | 3e1e767b-66a5-4f38-8142-84d40d447f92 | 2025-07-28 | Boxed warning, Warnings, Adverse reactions | 313989 310384 310385 I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE | Aurobindo Pharma Limited | d0f00a25-1aec-42fd-a301-d3710ae3e1f3 | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | 313989 310384 310385 I9W7N6B1KJ |
| FLUOXETINE | FLUOXETINE | Strides Pharma Science Limited | ca749349-d0e1-4b7c-b4c0-e392e72cf0f6 | 2025-07-02 | Boxed warning, Warnings, Adverse reactions | I9W7N6B1KJ |
| FLUOXETINE | FLUOXETINE | Saptalis Pharmaceuticals, LLC. | 4527c502-b28c-449f-ad2d-7daf21563cfa | 2025-06-23 | Boxed warning, Warnings, Adverse reactions | I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE | Bryant Ranch Prepack | ada19ae4-f3bd-47fa-a5c3-a6bb3aa34943 | 2025-06-02 | Boxed warning, Warnings, Adverse reactions | I9W7N6B1KJ |
| fluoxetine hydrochloride | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 80816531-9db3-492b-aebc-4681bf3c1554 | 2025-04-23 | Boxed warning, Warnings, Adverse reactions | I9W7N6B1KJ |
| fluoxetine hydrochloride | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | da785a8a-d897-494e-9fd2-1d09b32f0190 | 2025-04-23 | Boxed warning, Warnings, Adverse reactions | I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE | PD-Rx Pharmaceuticals, Inc. | 620ecf00-5473-4420-afd1-94b5b38e7301 | 2025-04-11 | Boxed warning, Warnings, Adverse reactions | 313989 I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE | American Health Packaging | 3276a2a4-61c7-4de6-b519-3aa8b62da88f | 2025-04-04 | Boxed warning, Warnings, Adverse reactions | I9W7N6B1KJ |
| Fluoxetine Hydrochloride | FLUOXETINE HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | f274f102-67ec-46e7-b248-533be2e3003b | 2025-03-06 | Boxed warning, Warnings, Adverse reactions | I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE | Alembic Pharmaceuticals Inc. | 9de65da4-73f8-4c88-8198-c92e63224ddb | 2025-02-27 | Boxed warning, Warnings, Adverse reactions | 313989 310384 310385 I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE | Bryant Ranch Prepack | 7a631271-9597-42a4-a924-1d06ecaba8c8 | 2025-02-12 | Boxed warning, Warnings, Adverse reactions | I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Redpharm Drug | 0b3da881-475d-cdee-e063-6394a90aee99 | 2025-01-23 | Boxed warning, Warnings, Adverse reactions | ANDA204597 310385 I9W7N6B1KJ |
| Fluoxetine HCL | FLUOXETINE HCL | Direct_Rx | 0259db51-e1ff-6e7a-e063-6394a90abace | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | ANDA204597 313989 I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | ScieGen Pharmaceuticals, Inc. | a7ba9184-7dad-4f82-a947-bb2cc6b760ce | 2025-01-20 | Boxed warning, Warnings, Adverse reactions | I9W7N6B1KJ |
| FLUOXETINE | FLUOXETINE HYDROCHLORIDE | DIRECT RX | 9b8d8da5-8c06-0942-e053-2995a90aa2c9 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | 313989 I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE | Advanced Rx Pharmacy of Tennessee, LLC | f917063a-226e-0978-e053-6294a90aeb4b | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | ANDA204597 80425-0313-1 80425-0313-3 80425-0313-2 80425-0313 80425031301 310385 2a9bf7d3-46d9-0dfa-e063-6394a90a76a4 f917063a-226e-0978-e053-6294a90aeb4b I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE | Par Health USA, LLC | 6fff3732-efc3-4cbd-a8fa-cde3181f03e6 | 2024-12-30 | Boxed warning, Warnings, Adverse reactions | I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | be4c5102-e0aa-3b89-e053-2a95a90a5d9d | 2024-12-19 | Boxed warning, Warnings, Adverse reactions | ANDA204597 313989 I9W7N6B1KJ |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | A-S Medication Solutions | 9a151528-2fe0-4059-b7b7-fcb4e80a51e3 | 2024-10-15 | Boxed warning, Warnings, Adverse reactions | 310384 310385 I9W7N6B1KJ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.