Duloxetine
- Product NDC
- 43063-878
- 11-digit product format
- 430630878
- Labeler code
- 43063
- Product ID
- 43063-878_dbd73293-e04d-91ef-e053-2995a90a6643
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine Hydrochloride
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA090778
- Marketing category
- ANDA
- Marketing start
- 2013-12-11
- 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 |
|---|
| 43063-878 | DULOXETINE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 24 | Legacy NDC | 20250417_471fec2a-ce5c-4f1a-954c-edf22999686c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-878-30 | 43063087830 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-878-30) | 2018-08-06 | 0000-00-00 | No | No | Current |
| 43063-878-90 | 43063087890 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-878-90) | 2020-07-27 | 0000-00-00 | No | No | Current |