Duloxetine
- Product NDC
- 82009-172
- 11-digit product format
- 820090172
- Labeler code
- 82009
- Product ID
- 82009-172_8bd1cf58-1f36-4c7e-a549-24bb4ec3e154
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Quallent Pharmaceuticals Health LLC
- Application
- ANDA208706
- Marketing category
- ANDA
- Marketing start
- 2025-07-01
- Substance
- DULOXETINE HYDROCHLORIDE
- Active strength
- 40 mg/1
- Pharmacologic classes
- Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Duloxetine
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DULOXETINE HYDROCHLORIDE | 40 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 9044SC542W |
| Rxcui | 596926, 596930, 596934, 616402 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| aebfdb62-b550-4c4f-9225-d5d3bbc7ab88 | Product name | 9 | 20210727 |
| 7dd29e28-6b69-499b-9257-12a3b46ca283 | Product name | 1 | 20191120 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82009-172-30 | Duloxetine | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 82009-172-30 | EA - Each | 82009-172 | 7d604184-e13c-426f-830e-0efb0b15ac87 | 1 | 2025-08-11 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 596926 | DULoxetine 20 MG Delayed Release Oral Capsule | PSN | b3b26383-9924-40f9-b4bb-43e30b70493e | 3 |
| 596930 | DULoxetine 30 MG Delayed Release Oral Capsule | PSN | b3b26383-9924-40f9-b4bb-43e30b70493e | 3 |
| 616402 | DULoxetine 40 MG Delayed Release Oral Capsule | PSN | b3b26383-9924-40f9-b4bb-43e30b70493e | 3 |
| 596934 | DULoxetine 60 MG Delayed Release Oral Capsule | PSN | b3b26383-9924-40f9-b4bb-43e30b70493e | 3 |
| 596926 | duloxetine 20 MG Delayed Release Oral Capsule | SCD | b3b26383-9924-40f9-b4bb-43e30b70493e | 3 |
| 596930 | duloxetine 30 MG Delayed Release Oral Capsule | SCD | b3b26383-9924-40f9-b4bb-43e30b70493e | 3 |
| 616402 | duloxetine 40 MG Delayed Release Oral Capsule | SCD | b3b26383-9924-40f9-b4bb-43e30b70493e | 3 |
| 596934 | duloxetine 60 MG Delayed Release Oral Capsule | SCD | b3b26383-9924-40f9-b4bb-43e30b70493e | 3 |
| 596926 | duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule | SY | b3b26383-9924-40f9-b4bb-43e30b70493e | 3 |
| 596930 | duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule | SY | b3b26383-9924-40f9-b4bb-43e30b70493e | 3 |
| 616402 | duloxetine 40 MG (as duloxetine HCl 44.9 MG) Delayed Release Oral Capsule | SY | b3b26383-9924-40f9-b4bb-43e30b70493e | 3 |
| 596934 | duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule | SY | b3b26383-9924-40f9-b4bb-43e30b70493e | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 82009-172-30 | 82009017230 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-172-30) | 2025-07-01 | No | No | Historical |