Duloxetine
- Product NDC
- 70710-1538
- 11-digit product format
- 707101538
- Labeler code
- 70710
- Product ID
- 70710-1538_a2356703-66f4-491b-874e-d4a4a2183788
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA090728
- Marketing category
- ANDA
- Marketing start
- 2014-05-27
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70710-1538-0 | 70710153800 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70710-1538-0) | 2017-04-06 | 0000-00-00 | No | No | Current |
| 70710-1538-3 | 70710153803 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70710-1538-3) | 2014-05-27 | 0000-00-00 | No | No | Current |
| 70710-1538-9 | 70710153809 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70710-1538-9) | 2014-05-27 | 0000-00-00 | No | No | Current |