Duloxetine
- Product NDC
- 68788-4025
- 11-digit product format
- 687884025
- Labeler code
- 68788
- Product ID
- 68788-4025_c5aac428-d929-4688-a9d5-4e9314aa62cc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE PELLETS
- Route
- ORAL
- Labeler
- Preferred Phamaceuticals Inc.
- Application
- ANDA090776
- Marketing category
- ANDA
- Marketing start
- 2025-09-15
- Substance
- DULOXETINE HYDROCHLORIDE
- Active strength
- 30 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
openFDA Listing Details
- Product ID
- 68788-4025_c5aac428-d929-4688-a9d5-4e9314aa62cc
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Duloxetine
- Generic name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE PELLETS
- Route
- ORAL
- Marketing start
- 2025-09-15
- Marketing category
- ANDA
- Application number
- ANDA090776
- Pharmacologic classes
- Norepinephrine Uptake Inhibitors [MoA]; Serotonin Uptake Inhibitors [MoA]; Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| DULOXETINE HYDROCHLORIDE | 30 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 9044SC542W |
| Rxcui | 596930, 596934 |
| Spl Set Id | c5aac428-d929-4688-a9d5-4e9314aa62cc |
| Manufacturer Name | Preferred Phamaceuticals Inc. |
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 |
|---|
| 68788-4025-3 | 68788402503 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-4025-3) | 2025-09-15 | No | No | Current |
| 68788-4025-6 | 68788402506 | 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-4025-6) | 2025-09-15 | No | No | Current |
| 68788-4025-9 | 68788402509 | 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-4025-9) | 2025-09-15 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Duloxetine | Preferred Phamaceuticals Inc. | 2025-09-15 | HUMAN PRESCRIPTION DRUG LABEL | 1 |