NDC 80425-0086-01 - 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
- 80425-0086
- Requested NDC
- 80425-0086-01
- Package NDCs from labels
- 80425-0086-2, 80425-0086-1, 80425-0086-01
- 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 | NuCare Pharmaceuticals, Inc. | 2c288791-2d8f-84bb-e063-6294a90a7e1e | 2025-01-20 | Boxed warning, Warnings, Adverse reactions | 596934 9044SC542W |
| Duloxetine | DULOXETINE | NuCare Pharmaceuticals, Inc. | 2b61c261-d7f2-4f9d-e063-6294a90acc24 | 2025-01-10 | Boxed warning, Warnings, Adverse reactions | 596930 9044SC542W |
| Duloxetine | DULOXETINE | NCS HealthCare of KY, LLC dba Vangard Labs | 54749431-430e-4532-97f7-4b1cd8dd252e | 2025-01-03 | Boxed warning, Warnings, Adverse reactions | 596926 596930 596934 9044SC542W |
| Duloxetine HCL DR | DULOXETINE HCL | Advanced Rx of Tennessee, LLC | af6f8abd-19ec-69e4-e053-2a95a90ab69e | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 596930 9044SC542W |
| Duloxetine HCL DR | DULOXETINE HCL | Advanced Rx of Tennessee, LLC | afd59273-75cb-5f33-e053-2995a90ab25f | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 596930 9044SC542W |
| Duloxetine HCL DR | DULOXETINE HCL | Advanced Rx of Tennessee, LLC | b33cbab8-1962-cb66-e053-2a95a90a4ae7 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | ANDA090776 80425-0086-1 80425-0086-2 80425-0086 80425008601 596930 2a98f01a-8da4-0770-e063-6294a90a7bab b33cbab8-1962-cb66-e053-2a95a90a4ae7 9044SC542W |
| Duloxetine HCL DR | DULOXETINE HCL | Advanced Rx Pharmacy of Tennessee, LLC | c4fa1d3b-f136-e14f-e053-2a95a90a6cfb | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 596930 9044SC542W |
| Duloxetine DR | DULOXETINE | Advanced Rx Pharmacy of Tennessee, LLC | b70035d4-5a3f-c5b5-e053-2995a90acac1 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 596934 9044SC542W |
| Duloxetine DR | DULOXETINE | Advanced Rx Pharmacy of Tennessee, LLC | f8c0bc80-b34e-daa8-e053-6394a90a05c2 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 596926 9044SC542W |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | df61b895-c358-827b-e053-2995a90a9b60 | 2024-12-26 | Boxed warning, Warnings, Adverse reactions | 596926 9044SC542W |
| Duloxetine | DULOXETINE | Bryant Ranch Prepack | 39e293d5-c575-49db-8389-7ac2269c49bb | 2024-12-10 | Boxed warning, Warnings, Adverse reactions | 596930 9044SC542W |
| Duloxetine | DULOXETINE | Zydus Lifesciences Limited | f36b414e-ace4-4f04-a80f-75bb25db430d | 2024-11-28 | 596926 596930 596934 9044SC542W | |
| Duloxetine | DULOXETINE HYDROCHLORIDE | Aurobindo Pharma Limited | 3adfceb3-5f89-4bcf-b874-e3cb572a98b6 | 2024-11-07 | Boxed warning, Warnings, Adverse reactions | 596926 596930 596934 9044SC542W |
| Duloxetine | DULOXETINE | Advanced Rx of Tennessee, LLC | 19afed24-39ad-daf1-e063-6394a90ad737 | 2024-10-22 | Boxed warning, Warnings, Adverse reactions | 596930 596934 9044SC542W |
| Duloxetine | DULOXETINE | Proficient Rx LP | 3dec1805-9a95-462e-8784-303004d500b1 | 2024-10-01 | Boxed warning, Warnings, Adverse reactions | ANDA090776 596926 9044SC542W |
| Duloxetine | DULOXETINE | Camber Pharmaceuticals, Inc. | b14feecc-04c6-4b2d-ba55-2e1dbef6b0d7 | 2024-09-28 | Boxed warning, Warnings, Adverse reactions | 596926 596930 596934 9044SC542W |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 41876761-9d5b-4190-a200-6a822c54582e | 2024-08-20 | Boxed warning, Warnings, Adverse reactions | 596930 9044SC542W |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 0c82422a-d493-4dda-8626-0d9baa25db8c | 2024-08-20 | Boxed warning, Warnings, Adverse reactions | 596934 9044SC542W |
| Duloxetine | DULOXETINE | Bryant Ranch Prepack | b19ba26f-4711-443e-83cf-5af7bb43a0a0 | 2024-08-20 | Boxed warning, Warnings, Adverse reactions | 596934 9044SC542W |
| Duloxetine | DULOXETINE | Bryant Ranch Prepack | 3fbdcc34-6166-4843-839c-33fed718ffb2 | 2024-08-07 | Boxed warning, Warnings, Adverse reactions | 596930 9044SC542W |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.