Duloxetine
- Product NDC
- 68071-3766
- 11-digit product format
- 680713766
- Labeler code
- 68071
- Product ID
- 68071-3766_2b61d5b5-490b-5494-e063-6294a90a3fa1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA208706
- Marketing category
- ANDA
- Marketing start
- 2017-03-16
- 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 |
|---|
| 68071-3766-9 | 68071376609 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-3766-9) | 2025-01-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Duloxetine | NuCare Pharmaceuticals, Inc. | 2025-01-10 | HUMAN PRESCRIPTION DRUG LABEL | 1 |