Duloxetine
- Product NDC
- 68788-4026
- 11-digit product format
- 687884026
- Labeler code
- 68788
- Product ID
- 68788-4026_c5aac428-d929-4688-a9d5-4e9314aa62cc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE PELLETS
- Route
- ORAL
- Labeler
- Preferred Phamaceuticals Inc.
- Application
- ANDA090776
- Marketing category
- ANDA
- Marketing start
- 2025-09-15
- Substance
- DULOXETINE HYDROCHLORIDE
- Active strength
- 60 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 9044SC542W | DULOXETINE HYDROCHLORIDE | 136434-34-9 | DULOXETINE HYDROCHLORIDE |
| O5TNM5N07U | DULOXETINE | 116539-59-4 | Duloxetine |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-4026-3 | 68788402603 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-4026-3) | 2025-09-15 | No | No | Historical |
| 68788-4026-6 | 68788402606 | 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-4026-6) | 2025-09-15 | No | No | Historical |
| 68788-4026-9 | 68788402609 | 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-4026-9) | 2025-09-15 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Duloxetine | Preferred Phamaceuticals Inc. | 2025-09-15 | HUMAN PRESCRIPTION DRUG LABEL | 1 |