Duloxetine
- Product NDC
- 71335-2625
- 11-digit product format
- 713352625
- Labeler code
- 71335
- Product ID
- 71335-2625_6606e4e5-52f7-4c60-b6ac-f7f76d926c6e
- 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
- 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
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Duloxetine
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| DULOXETINE HYDROCHLORIDE | 60 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 9044SC542W |
| Rxcui | 596934 |
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 |
|---|
| 71335-2625-1 | 71335262501 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2625-1) | 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 |