Duloxetine
- Product NDC
- 63629-8748
- 11-digit product format
- 636298748
- Labeler code
- 63629
- Product ID
- 63629-8748_b9f90234-c0e9-4c82-8787-d441d2181384
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE PELLETS
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA090776
- Marketing category
- ANDA
- Marketing start
- 2013-12-17
- 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 |
|---|
| 63629-8748-1 | 63629874801 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (63629-8748-1) | 2013-12-17 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Duloxetine | Bryant Ranch Prepack | 2024-05-30 | HUMAN PRESCRIPTION DRUG LABEL | 104 |