Duloxetine
- Product NDC
- 50090-6406
- 11-digit product format
- 500906406
- Labeler code
- 50090
- Product ID
- 50090-6406_eaec6517-6ac0-4432-bbb6-9b3c70e7a1d9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA090694
- Marketing category
- ANDA
- Marketing start
- 2013-12-11
- 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 |
|---|
| 50090-6406-0 | 50090640600 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6406-0) | 2023-03-23 | No | No | Historical |
| 50090-6406-1 | 50090640601 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6406-1) | 2023-07-24 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Duloxetine | A-S Medication Solutions | 2024-06-10 | HUMAN PRESCRIPTION DRUG LABEL | 13 |