| Product NDC: | 42254-002 |
| Proprietary Name: | FENTANYL TRANSDERMAL SYSTEM |
| Non Proprietary Name: | fentanyl transdermal system |
| Active Ingredient(s): | 50 ug/h & nbsp; fentanyl transdermal system |
| Administration Route(s): | TRANSDERMAL |
| Dosage Form(s): | PATCH, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 42254-002 |
| Labeler Name: | Rebel Distributors Corp. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA077154 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20110209 |
| Package NDC: | 42254-002-05 |
| Package Description: | 5 POUCH in 1 CARTON (42254-002-05) > 1 PATCH in 1 POUCH > 72 h in 1 PATCH |
| NDC Code | 42254-002-05 |
| Proprietary Name | FENTANYL TRANSDERMAL SYSTEM |
| Package Description | 5 POUCH in 1 CARTON (42254-002-05) > 1 PATCH in 1 POUCH > 72 h in 1 PATCH |
| Product NDC | 42254-002 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | fentanyl transdermal system |
| Dosage Form Name | PATCH, EXTENDED RELEASE |
| Route Name | TRANSDERMAL |
| Start Marketing Date | 20110209 |
| Marketing Category Name | ANDA |
| Labeler Name | Rebel Distributors Corp. |
| Substance Name | FENTANYL |
| Strength Number | 50 |
| Strength Unit | ug/h |
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |