Duloxetine
- Product NDC
- 68071-3779
- 11-digit product format
- 680713779
- Labeler code
- 68071
- Product ID
- 68071-3779_2d7c292f-ed92-07c0-e063-6294a90ae805
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE PELLETS
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA090776
- Marketing category
- ANDA
- Marketing start
- 2013-12-17
- Substance
- DULOXETINE HYDROCHLORIDE
- Active strength
- 30 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 |
|---|
| 68071-3779-3 | 68071377903 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68071-3779-3) | 2025-02-06 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Duloxetine | NuCare Pharmaceuticals,Inc. | 2025-02-06 | HUMAN PRESCRIPTION DRUG LABEL | 1 |