| Product NDC: | 35356-607 | 
| Proprietary Name: | Butrans | 
| Non Proprietary Name: | buprenorphine | 
| Active Ingredient(s): | 5 ug/h & nbsp; buprenorphine | 
| Administration Route(s): | TRANSDERMAL | 
| Dosage Form(s): | PATCH, EXTENDED RELEASE | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 35356-607 | 
| 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: | 35356-607-04 | 
| Package Description: | 4 POUCH in 1 CARTON (35356-607-04) > 1 PATCH in 1 POUCH > 168 h in 1 PATCH | 
| NDC Code | 35356-607-04 | 
| Proprietary Name | Butrans | 
| Package Description | 4 POUCH in 1 CARTON (35356-607-04) > 1 PATCH in 1 POUCH > 168 h in 1 PATCH | 
| Product NDC | 35356-607 | 
| 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 | 5 | 
| Strength Unit | ug/h | 
| Pharmaceutical Classes | Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] |