Duloxetine
- Product NDC
- 0904-7044
- 11-digit product format
- 009047044
- Labeler code
- 0904
- Product ID
- 0904-7044_abd32cc2-e506-412d-9e59-01219830bba8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine Hydrochloride
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA090778
- 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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7044 | DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS] | 8 | Legacy NDC | 20250424_fdc774b5-c8f2-4daf-94cb-7e73548b541a.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-7044-61 | 00904704461 | 100 BLISTER PACK in 1 CARTON (0904-7044-61) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK | 100 blister pack | 2013-12-11 | 0000-00-00 | No | No | Current |