Duloxetine
- Product NDC
- 71205-445
- 11-digit product format
- 712050445
- Labeler code
- 71205
- Product ID
- 71205-445_d0a48dfd-af34-470b-9e1f-7678203e9ae5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA203197
- Marketing category
- ANDA
- Marketing start
- 2012-05-01
- 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 |
|---|
| 71205-445-30 | 71205044530 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-445-30) | 2020-05-19 | No | No | Historical |
| 71205-445-60 | 71205044560 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-445-60) | 2020-05-19 | No | No | Historical |
| 71205-445-90 | 71205044590 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-445-90) | 2020-05-19 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Duloxetine | Proficient Rx LP | 2020-05-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |