NDC 80425-0086-02 - 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
- 80425-0086
- Requested NDC
- 80425-0086-02
- Package NDCs from labels
- 80425-0086-2, 80425-0086-1, 80425-0086-02
- 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 |
|---|---|---|---|
| Duloxetine HCL DR - 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 |
|---|---|---|---|---|---|---|
| 80425-0086-1 | Duloxetine HCLDR | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 30 | 8 | |
| 80425-0086-2 | Duloxetine HCLDR | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 60 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0086 | DULOXETINE HCL DR (DULOXETINE HCL) CAPSULE, DELAYED RELEASE PELLETS [ADVANCED RX OF TENNESSEE, LLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250101_b33cbab8-1962-cb66-e053-2a95a90a4ae7.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0086-1 | EA - Each | 80425-0086 | 102f4941-252e-4913-9548-2e4635b2794d | 1 | 2023-04-07 |
| 80425-0086-2 | EA - Each | 80425-0086 | 8b2a3537-4838-4173-a964-1e4ee15359c0 | 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 | DULOXETINE | St. Mary's Medical Park Pharmacy | 9221f3e5-17b8-ea74-e053-2a95a90ad1a8 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 596934 9044SC542W |
| Duloxetine | DULOXETINE | REMEDYREPACK INC. | ac903bda-76af-4aba-9c8a-ebf7066e05ee | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | 596934 9044SC542W |
| Duloxetine | DULOXETINE | St. Mary's Medical Park Pharmacy | 9221aea1-8de1-b94e-e053-2a95a90a1eae | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | 596930 9044SC542W |
| Duloxetine | DULOXETINE | Golden State Medical Supply, Inc. | 569582d5-cb6d-735e-e063-6394a90abfb6 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | 596926 596930 596934 9044SC542W |
| Duloxetine | DULOXETINE | REMEDYREPACK INC. | c66fb2ee-f64a-4d28-a692-e8dc7b61fbc9 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | 596926 9044SC542W |
| Duloxetine | DULOXETINE | ANI Pharmaceuticals, Inc. | fb37745f-fb40-4f7f-8143-ea1874c38e1b | 2026-07-13 | Boxed warning, Warnings, Adverse reactions | 596926 596930 596934 9044SC542W |
| Duloxetine | DULOXETINE | REMEDYREPACK INC. | 1d3a45f3-3854-4d0c-9241-770aa24063fd | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | 596930 9044SC542W |
| Duloxetine | DULOXETINE | REMEDYREPACK INC. | 461d769c-b787-4bc7-b4a6-7a5f33ae9d45 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | 596934 9044SC542W |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | Yaopharma Co., Ltd. | 90224073-178d-7ec5-e053-2995a90a20fc | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | 596926 596930 596934 9044SC542W |
| Duloxetine | DULOXETINE | HAWAII REPACK, INC | b32a39d8-5f1a-4e44-bc46-b65925bde753 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | ANDA090776 596926 596930 596934 9044SC542W |
| Duloxetine | DULOXETINE | HAWAII REPACK, INC. | 79bfd6be-a1ff-4786-b4e2-abbd0a3e3932 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 596926 596930 596934 9044SC542W |
| Duloxetine | DULOXETINE | REMEDYREPACK INC. | b149641a-03e6-4fee-91f3-7ba8e01196bd | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 596930 9044SC542W |
| Duloxetine | DULOXETINE | St. Mary's Medical Park Pharmacy | 39fa4247-e864-f653-e063-6394a90ac98d | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | 596926 9044SC542W |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | b9f20917-9529-4c62-bafe-baae7f8d6c77 | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | 596934 9044SC542W |
| Duloxetine | DULOXETINE | Preferred Pharmaceuticals Inc. | 22a2ad76-0841-46fe-85e1-101afd924939 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 596926 9044SC542W |
| Duloxetine | DULOXETINE | Lupin Pharmaceuticals, Inc. | 829a4f51-c882-4b64-81f3-abfb03a52ebe | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | 596926 596930 596934 9044SC542W |
| Duloxetine | DULOXETINE | REMEDYREPACK INC. | ed164dbb-e713-42d1-a78e-31145578b9f8 | 2026-05-18 | Boxed warning, Warnings, Adverse reactions | 596930 9044SC542W |
| Duloxetine | DULOXETINE | Bryant Ranch Prepack | c877bb68-759f-4d45-8bef-872554da4551 | 2026-05-08 | Boxed warning, Warnings, Adverse reactions | 596934 9044SC542W |
| 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 |