Duloxetine
- Product NDC
- 31722-583
- 11-digit product format
- 317220583
- Labeler code
- 31722
- Product ID
- 31722-583_74de48c9-1785-40b1-b55f-e3bc1641f8d9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA204343
- Marketing category
- ANDA
- Marketing start
- 2016-08-11
- Marketing end
- 0000-00-00
- Substance
- DULOXETINE HYDROCHLORIDE
- Active strength
- 60 mg/1
- Pharmacologic classes
- Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 |
|---|
| 31722-583-01 | 31722058301 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-583-01) | 2016-08-11 | 0000-00-00 | No | No | Current |
| 31722-583-30 | 31722058330 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-583-30) | 2016-08-11 | 0000-00-00 | No | No | Current |
| 31722-583-31 | 31722058331 | 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (31722-583-31) | 2016-08-11 | 0000-00-00 | No | No | Current |
| 31722-583-32 | 31722058332 | 90 CAPSULE, DELAYED RELEASE in 1 CARTON (31722-583-32) | 2016-08-11 | 0000-00-00 | No | No | Current |