Duloxetine
- Product NDC
- 80425-0311
- 11-digit product format
- 804250311
- Labeler code
- 80425
- Product ID
- 80425-0311_2a9bfe6a-6d6d-b262-e063-6294a90a1cf3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA208706
- Marketing category
- ANDA
- Marketing start
- 2023-04-07
- 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 |
|---|
| 80425-0311-1 | 80425031101 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0311-1) | 2023-04-07 | No | No | Historical |
| 80425-0311-2 | 80425031102 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0311-2) | 2023-04-07 | No | No | Historical |
| 80425-0311-3 | 80425031103 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0311-3) | 2023-04-07 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Duloxetine HCL DR Capsules | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL | 2 |