Duloxetine hydrochloride
- Product NDC
- 0615-8203
- 11-digit product format
- 006158203
- Labeler code
- 0615
- Product ID
- 0615-8203_ebb3c40d-0ae5-43c4-bdf1-cfaca9c90224
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetin hydrochloride
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA090774
- Marketing category
- ANDA
- Marketing start
- 2013-12-11
- Marketing end
- 0000-00-00
- Substance
- DULOXETINE HYDROCHLORIDE
- Active strength
- 30 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
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0615-8203-05 | 00615820305 | 15 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8203-05) | 2019-04-10 | 0000-00-00 | No | No | Current |
| 0615-8203-39 | 00615820339 | 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8203-39) | 2013-12-11 | 0000-00-00 | No | No | Current |