Duloxetine Hydrochloride
- Product NDC
- 0904-6454
- 11-digit product format
- 009046454
- Labeler code
- 0904
- Product ID
- 0904-6454_6566e7d5-91c3-4a9d-9680-7e3c8f6eae87
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine Hydrochloride
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA202045
- Marketing category
- ANDA
- Marketing start
- 2014-06-13
- Marketing end
- 2022-10-31
- 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
- 0000-00-00
- 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 |
|---|
| 0904-6454-61 | 00904645461 | 100 BLISTER PACK in 1 CARTON (0904-6454-61) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK | 100 blister pack | 2014-06-13 | 2022-10-31 | No | No | Current |