Duloxetine
- Product NDC
- 68788-8623
- 11-digit product format
- 687888623
- Labeler code
- 68788
- Product ID
- 68788-8623_5628b5ce-a32d-4bc3-9171-efe022cf4a37
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA090694
- Marketing category
- ANDA
- Marketing start
- 2024-04-08
- 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 |
|---|
| 68788-8623-3 | 68788862303 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8623-3) | 2024-04-08 | No | No | Historical |
| 68788-8623-6 | 68788862306 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8623-6) | 2024-04-08 | No | No | Historical |
| 68788-8623-9 | 68788862309 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8623-9) | 2024-04-08 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Duloxetine | Preferred Pharmaceuticals Inc. | 2025-04-04 | HUMAN PRESCRIPTION DRUG LABEL | 2 |