Duloxetine
- Product NDC
- 65862-453
- 11-digit product format
- 658620453
- Labeler code
- 65862
- Product ID
- 65862-453_f64ca39e-f7fc-45e5-a2bf-23b39ada6998
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine Hydrochloride
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA090778
- Marketing category
- ANDA
- Marketing start
- 2013-12-11
- 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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65862-453-30 | 65862045330 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-453-30) | | 2013-12-11 | 0000-00-00 | No | No | Current |
| 65862-453-39 | 65862045339 | 3000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-453-39) | | 2013-12-11 | 0000-00-00 | No | No | Current |
| 65862-453-78 | 65862045378 | 10 BLISTER PACK in 1 CARTON (65862-453-78) > 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (65862-453-10) | 10 blister pack | 2013-12-11 | 0000-00-00 | No | No | Current |
| 65862-453-90 | 65862045390 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-453-90) | | 2013-12-11 | 0000-00-00 | No | No | Current |
| 65862-453-99 | 65862045399 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-453-99) | | 2013-12-11 | 0000-00-00 | No | No | Current |