Duloxetine
- Product NDC
- 71335-2624
- 11-digit product format
- 713352624
- Labeler code
- 71335
- Product ID
- 71335-2624_f8e683e1-9c7d-4ec2-bb01-6a3343f5f018
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Duloxetine
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| DULOXETINE HYDROCHLORIDE | 20 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 9044SC542W |
| Rxcui | 596926 |
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 |
|---|
| 71335-2624-1 | 71335262401 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2624-1) | 2025-06-02 | No | No | Historical |
| 71335-2624-2 | 71335262402 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2624-2) | 2025-06-02 | No | No | Historical |
| 71335-2624-3 | 71335262403 | 28 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2624-3) | 2025-06-02 | No | No | Historical |
| 71335-2624-4 | 71335262404 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2624-4) | 2025-06-02 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Duloxetine | Bryant Ranch Prepack | 2025-06-02 | HUMAN PRESCRIPTION DRUG LABEL | 1 |