Duloxetine
- Product NDC
- 76420-236
- 11-digit product format
- 764200236
- Labeler code
- 76420
- Product ID
- 76420-236_e347f58a-9f2f-7e64-e053-2a95a90a528b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE PELLETS
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA090776
- Marketing category
- ANDA
- Marketing start
- 2013-12-17
- 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 |
|---|
| 76420-236-30 | 76420023630 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (76420-236-30) | 2022-07-07 | No | No | Historical |
| 76420-236-60 | 76420023660 | 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (76420-236-60) | 2022-07-07 | No | No | Historical |
| 76420-236-90 | 76420023690 | 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (76420-236-90) | 2022-07-07 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Duloxetine | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2022-07-07 | HUMAN PRESCRIPTION DRUG LABEL | 1 |