| Product NDC: | 35356-605 |
| Proprietary Name: | Butrans |
| Non Proprietary Name: | buprenorphine |
| Active Ingredient(s): | 10 ug/h & nbsp; buprenorphine |
| Administration Route(s): | TRANSDERMAL |
| Dosage Form(s): | PATCH, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 35356-605 |
| Labeler Name: | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021306 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20120326 |
| Package NDC: | 35356-605-04 |
| Package Description: | 4 POUCH in 1 CARTON (35356-605-04) > 1 PATCH in 1 POUCH > 168 h in 1 PATCH |
| NDC Code | 35356-605-04 |
| Proprietary Name | Butrans |
| Package Description | 4 POUCH in 1 CARTON (35356-605-04) > 1 PATCH in 1 POUCH > 168 h in 1 PATCH |
| Product NDC | 35356-605 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | buprenorphine |
| Dosage Form Name | PATCH, EXTENDED RELEASE |
| Route Name | TRANSDERMAL |
| Start Marketing Date | 20120326 |
| Marketing Category Name | NDA |
| Labeler Name | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC |
| Substance Name | BUPRENORPHINE |
| Strength Number | 10 |
| Strength Unit | ug/h |
| Pharmaceutical Classes | Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] |