DURAGESIC
- Product NDC
- 50458-101
- 11-digit product format
- 504580101
- Labeler code
- 50458
- Product ID
- 50458-101_d9a349c8-b6a3-11ec-bed1-85d730367705
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fentanyl
- Dosage form
- PATCH
- Route
- TRANSDERMAL
- Labeler
- Janssen Pharmaceuticals, Inc.
- Application
- NDA019813
- Marketing category
- NDA
- Marketing start
- 2018-11-05
- Marketing end
- 2022-09-15
- Substance
- FENTANYL
- Active strength
- 13 ug/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- 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 |
|---|
| 50458-101-05 | 50458010105 | 5 POUCH in 1 BOX (50458-101-05) > 1 PATCH in 1 POUCH | 5 pouch | 2018-11-15 | 0000-00-00 | No | No | Current |