Fentanyl System is a Transdermal Patch in the Human Prescription Drug category. It is labeled and distributed by Alvogen. The primary component is Fentanyl.
| Product ID | 47781-427_19344ad1-a2c3-4562-8db8-8f60fc2a6ef3 |
| NDC | 47781-427 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Fentanyl System |
| Generic Name | Fentanyl |
| Dosage Form | Patch |
| Route of Administration | TRANSDERMAL |
| Marketing Start Date | 2016-11-04 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA202097 |
| Labeler Name | Alvogen |
| Substance Name | FENTANYL |
| Active Ingredient Strength | 75 ug/1 |
| Pharm Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
| DEA Schedule | CII |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2016-11-04 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA202097 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2016-11-04 |
| Marketing Category | ANDA |
| Application Number | ANDA202097 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-11-04 |
| Marketing End Date | 2018-12-13 |
| Ingredient | Strength |
|---|---|
| FENTANYL | 75 ug/1 |
| SPL SET ID: | 242759ef-cb6d-4e3e-9f8d-5e31efa1f289 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 47781-423 | Fentanyl System | Fentanyl System |
| 47781-426 | Fentanyl System | Fentanyl System |
| 47781-424 | Fentanyl System | Fentanyl System |
| 47781-428 | Fentanyl System | Fentanyl System |
| 47781-427 | Fentanyl System | Fentanyl System |
| 55700-597 | Fentanyl System | Fentanyl System |
| 0378-9119 | FENTANYL | FENTANYL |
| 0378-9121 | FENTANYL | FENTANYL |
| 0378-9122 | FENTANYL | FENTANYL |
| 0378-9123 | FENTANYL | FENTANYL |
| 0378-9124 | FENTANYL | FENTANYL |
| 0378-9125 | FENTANYL | FENTANYL |
| 0378-9126 | FENTANYL | FENTANYL |
| 0378-9127 | FENTANYL | FENTANYL |
| 0591-3198 | Fentanyl | Fentanyl |
| 0591-3212 | Fentanyl | Fentanyl |
| 0591-3213 | Fentanyl | Fentanyl |
| 0591-3214 | Fentanyl | Fentanyl |
| 0781-7240 | Fentanyl | Fentanyl |
| 0781-7241 | Fentanyl | Fentanyl |
| 0781-7242 | Fentanyl | Fentanyl |
| 0781-7243 | Fentanyl | Fentanyl |
| 0781-7244 | Fentanyl | Fentanyl |
| 20482-001 | SUBSYS | fentanyl |
| 20482-002 | SUBSYS | fentanyl |