Duloxetine
- Product NDC
- 70518-4440
- 11-digit product format
- 705184440
- Labeler code
- 70518
- Product ID
- 70518-4440_3c53fdd6-1d4b-530d-e063-6294a90aed43
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA090694
- Marketing category
- ANDA
- Marketing start
- 2025-08-14
- Substance
- DULOXETINE HYDROCHLORIDE
- Active strength
- 20 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 |
|---|
| 70518-4440-0 | 70518444000 | 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (70518-4440-0) | 2025-08-14 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Duloxetine | REMEDYREPACK INC. | 2025-08-14 | HUMAN PRESCRIPTION DRUG LABEL | 1 |