Duloxetine
- Product NDC
- 71335-2537
- 11-digit product format
- 713352537
- Labeler code
- 71335
- Product ID
- 71335-2537_de262c83-60e7-499a-9c2a-d6a5aa79c4d0
- 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
- 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
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 |
|---|
| 71335-2537-1 | 71335253701 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2537-1) | 2024-12-10 | No | No | Historical |
| 71335-2537-2 | 71335253702 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2537-2) | 2024-12-10 | No | No | Historical |
| 71335-2537-3 | 71335253703 | 28 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2537-3) | 2024-12-10 | No | No | Historical |
| 71335-2537-4 | 71335253704 | 6 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2537-4) | 2024-12-10 | No | No | Historical |
| 71335-2537-5 | 71335253705 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2537-5) | 2024-12-10 | No | No | Historical |
| 71335-2537-6 | 71335253706 | 15 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2537-6) | 2024-12-10 | No | No | Historical |
| 71335-2537-7 | 71335253707 | 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2537-7) | 2024-12-10 | No | No | Historical |
| 71335-2537-8 | 71335253708 | 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2537-8) | 2024-12-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Duloxetine | Bryant Ranch Prepack | 2024-12-10 | HUMAN PRESCRIPTION DRUG LABEL | 1 |