Fentanyl System
- Product NDC
- 55700-597
- 11-digit product format
- 557000597
- Labeler code
- 55700
- Product ID
- 55700-597_0be26ea2-6947-47b9-8eb0-96b2426607e6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fentanyl
- Dosage form
- PATCH
- Route
- TRANSDERMAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA202097
- Marketing category
- ANDA
- Marketing start
- 2018-04-13
- Marketing end
- 0000-00-00
- Substance
- FENTANYL
- Active strength
- 25 ug/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- 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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55700-597-05 | 55700059705 | 1 POUCH in 1 CARTON (55700-597-05) > 5 PATCH in 1 POUCH | 1 pouch | 2018-04-13 | 0000-00-00 | No | No | Current |