DULOXETINE
- Product NDC
- 43353-960
- 11-digit product format
- 433530960
- Labeler code
- 43353
- Product ID
- 43353-960_7431f3dd-bf89-4f5a-a9be-7118b0afbac9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DULOXETINE HYDROCHLORIDE
- Dosage form
- CAPSULE, DELAYED RELEASE PELLETS
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA203088
- Marketing category
- ANDA
- Marketing start
- 2014-06-11
- Marketing end
- 0000-00-00
- Substance
- DULOXETINE HYDROCHLORIDE
- Active strength
- 30 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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-960 | DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 7 | Legacy NDC | 20240410_c94339ab-3aaf-4cc9-b770-650b433bcce8.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-960-30 | 43353096030 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (43353-960-30) | 2017-08-08 | 0000-00-00 | No | No | Current |
| 43353-960-83 | 43353096083 | 3600 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (43353-960-83) | 2014-08-16 | 0000-00-00 | No | No | Current |