Duloxetine
- Product NDC
- 55700-628
- 11-digit product format
- 557000628
- Labeler code
- 55700
- Product ID
- 55700-628_87922ff5-6e15-4594-ba30-48bc4cf574d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Quality Care Products LLC
- Application
- ANDA208706
- Marketing category
- ANDA
- Marketing start
- 2018-05-18
- Marketing end
- 0000-00-00
- Substance
- DULOXETINE HYDROCHLORIDE
- Active strength
- 60 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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55700-628 | DULOXETINE CAPSULE, DELAYED RELEASE [QUALITY CARE PRODUCTS LLC] | 9 | Legacy NDC | 20241220_e4728363-a9ce-456b-ab5e-7e66b64f8787.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55700-628-30 | 55700062830 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-628-30) | 2018-05-18 | 0000-00-00 | No | No | Current |
| 55700-628-60 | 55700062860 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-628-60) | 2018-05-18 | 0000-00-00 | No | No | Current |
| 55700-628-90 | 55700062890 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-628-90) | 2022-03-22 | 0000-00-00 | No | No | Current |