Duloxetine Hydrochloride
- Product NDC
- 63187-716
- 11-digit product format
- 631870716
- Labeler code
- 63187
- Product ID
- 63187-716_6f8cd8f8-8650-4080-a488-ed1c497c5f5f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine Hydrochloride
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA202045
- Marketing category
- ANDA
- Marketing start
- 2014-06-13
- Marketing end
- 0000-00-00
- Substance
- DULOXETINE HYDROCHLORIDE
- Active strength
- 20 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 |
|---|
| 63187-716 | DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 3 | Legacy NDC | 20191121_1a1f3657-8482-421e-a283-8c43eee47133.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-716-30 | 63187071630 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-716-30) | 2016-06-01 | 0000-00-00 | No | No | Current |
| 63187-716-60 | 63187071660 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-716-60) | 2016-06-01 | 0000-00-00 | No | No | Current |
| 63187-716-90 | 63187071690 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-716-90) | 2016-06-01 | 0000-00-00 | No | No | Current |