NDC 80425-0146-01 - Duloxetine HCL DR
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
- 80425-0146
- Requested NDC
- 80425-0146-01
- Package NDCs from labels
- 80425-0146-2, 80425-0146-1, 80425-0146-3, 80425-0146-01
- 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 |
|---|---|---|---|
| Duloxetine HCL DR - 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 |
|---|---|---|---|---|---|---|
| 80425-0146-1 | Duloxetine HCLDR | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | 9 | |
| 80425-0146-2 | Duloxetine HCLDR | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 60 | 9 | |
| 80425-0146-3 | Duloxetine HCLDR | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | 9 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0146 | DULOXETINE HCL DR (DULOXETINE HCL) CAPSULE, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 9 | Current NDC, Legacy NDC, 3 package rows | 20250101_c4fa1d3b-f136-e14f-e053-2a95a90a6cfb.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0146-1 | EA - Each | 80425-0146 | 3c472cb1-ec7d-4cd2-95f2-5fcd67ca1786 | 1 | 2023-06-06 |
| 80425-0146-2 | EA - Each | 80425-0146 | 574073d7-581d-4d39-befa-18705d964877 | 1 | 2023-06-06 |
| 80425-0146-3 | EA - Each | 80425-0146 | d2406371-2b40-4cdf-8c91-8c85a09eb3f0 | 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 |
|---|---|---|---|---|---|---|
| DULOXETINE HYDROCHLORIDE | DULOXETINE | Alembic Pharmaceuticals Inc. | 39453971-766d-45bf-a0fd-4658d72bae72 | 2026-05-06 | Boxed warning, Warnings, Adverse reactions | 596926 596930 596934 9044SC542W |
| DULOXETINE HYDROCHLORIDE | DULOXETINE | Alembic Pharmaceuticals Limited | 05a744a5-64ef-42d7-a19c-568be5a272d4 | 2026-04-22 | Boxed warning, Warnings, Adverse reactions | 596926 596930 596934 9044SC542W |
| Duloxetine | DULOXETINE | QPharma, Inc. | 4f205401-39ac-7009-e063-6394a90aaa8c | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | 596934 9044SC542W |
| Duloxetine | DULOXETINE | Preferred Pharmaceuticals Inc. | 9141b9d3-8d4d-43ec-acf9-e1b620590c4b | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | 596930 9044SC542W |
| Duloxetine | DULOXETINE | Preferred Pharmaceuticals Inc. | e86eb765-ac9c-4ed9-bce8-819151559394 | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | ANDA208706 596930 9044SC542W |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 29eacc40-cbec-4cc9-8556-773346617e85 | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | 596926 9044SC542W |
| Duloxetine | DULOXETINE | NuCare Pharmaceuticals, Inc. | 4e42a04a-ab8e-3ec9-e063-6394a90a4565 | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | ANDA208706 596926 9044SC542W |
| Duloxetine | DULOXETINE | NuCare Pharmaceuticals,Inc. | 075fc7c9-7b4b-b9c3-e063-6394a90a926e | 2026-03-19 | Boxed warning, Warnings, Adverse reactions | ANDA208706 596934 9044SC542W |
| Duloxetine | DULOXETINE | Almatica Pharma LLC | bb2ca3bf-983c-1e4a-a91d-dc7dee66d741 | 2026-03-02 | Boxed warning, Warnings, Adverse reactions | 9044SC542W |
| Duloxetine | DULOXETINE | Actavis Pharma, Inc. | 9dab9154-b86f-40dc-a4d1-18e6534dbc78 | 2026-02-24 | Boxed warning, Warnings, Adverse reactions | 596926 596930 596934 9044SC542W |
| Duloxetine | DULOXETINE | A-S Medication Solutions | 3424a326-9543-44f7-b31c-f84e12509238 | 2026-02-17 | Boxed warning, Warnings, Adverse reactions | 596934 9044SC542W |
| Duloxetine | DULOXETINE | A-S Medication Solutions | cdd870a9-3bed-42fc-b175-48aed5321969 | 2026-02-17 | Boxed warning, Warnings, Adverse reactions | 596934 9044SC542W |
| Duloxetine D/R | DULOXETINE D/R | Direct_Rx | 4a66fde2-4cce-b92e-e063-6294a90a63ee | 2026-02-09 | Boxed warning, Warnings, Adverse reactions | ANDA208706 596930 9044SC542W |
| Duloxetine | DULOXETINE | Bryant Ranch Prepack | 5fa0eda4-0886-415c-a30c-ae9729f16974 | 2026-02-06 | Boxed warning, Warnings, Adverse reactions | ANDA208706 596926 9044SC542W |
| Duloxetine | DULOXETINE | Preferred Pharmaceuticals Inc. | ae381859-be09-43e1-8b56-d0d8f4b49020 | 2026-01-21 | Boxed warning, Warnings, Adverse reactions | 616402 9044SC542W |
| Duloxetine | DULOXETINE | REMEDYREPACK INC. | 9286ec0b-45ae-4a09-a0ad-556ec92aab63 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | ANDA208706 596926 9044SC542W |
| Duloxetine | DULOXETINE | REMEDYREPACK INC. | ba4adb77-45be-4310-a877-766692f22e5e | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | ANDA208706 596934 9044SC542W |
| Duloxetine | DULOXETINE | Coupler LLC | 3edce3bd-1102-5951-e063-6394a90ae6c5 | 2026-01-09 | Boxed warning, Warnings, Adverse reactions | 596930 9044SC542W |
| Duloxetine | DULOXETINE | Coupler LLC | 3f649b01-0969-cc71-e063-6394a90a9df5 | 2026-01-09 | Boxed warning, Warnings, Adverse reactions | 596934 9044SC542W |
| Duloxetine | DULOXETINE | Bryant Ranch Prepack | ff118c08-2e64-4416-a996-fd9de45d018a | 2026-01-07 | Boxed warning, Warnings, Adverse reactions | 596934 9044SC542W |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.