| Product NDC: | 20482-004 |
| Proprietary Name: | SUBSYS |
| Non Proprietary Name: | FENTANYL |
| Active Ingredient(s): | .4 mg/1 & nbsp; FENTANYL |
| Administration Route(s): | SUBLINGUAL |
| Dosage Form(s): | SPRAY |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 20482-004 |
| Labeler Name: | Insys Therapeutics, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA202788 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20120313 |
| Package NDC: | 20482-004-10 |
| Package Description: | 10 BLISTER PACK in 1 CARTON (20482-004-10) > 1 BOTTLE, SPRAY in 1 BLISTER PACK > 1 SPRAY in 1 BOTTLE, SPRAY |
| NDC Code | 20482-004-10 |
| Proprietary Name | SUBSYS |
| Package Description | 10 BLISTER PACK in 1 CARTON (20482-004-10) > 1 BOTTLE, SPRAY in 1 BLISTER PACK > 1 SPRAY in 1 BOTTLE, SPRAY |
| Product NDC | 20482-004 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | FENTANYL |
| Dosage Form Name | SPRAY |
| Route Name | SUBLINGUAL |
| Start Marketing Date | 20120313 |
| Marketing Category Name | NDA |
| Labeler Name | Insys Therapeutics, Inc. |
| Substance Name | FENTANYL |
| Strength Number | .4 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |