| Product NDC: | 0245-0422 |
| Proprietary Name: | Fentanyl |
| Non Proprietary Name: | Fentanyl |
| Active Ingredient(s): | 75 ug/h & nbsp; Fentanyl |
| Administration Route(s): | TRANSDERMAL |
| Dosage Form(s): | PATCH, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0245-0422 |
| Labeler Name: | Upsher-Smith Laboratories, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA077775 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20130301 |
| Package NDC: | 0245-0422-05 |
| Package Description: | 5 POUCH in 1 CARTON (0245-0422-05) > 1 PATCH in 1 POUCH > 72 h in 1 PATCH (0245-0422-89) |
| NDC Code | 0245-0422-05 |
| Proprietary Name | Fentanyl |
| Package Description | 5 POUCH in 1 CARTON (0245-0422-05) > 1 PATCH in 1 POUCH > 72 h in 1 PATCH (0245-0422-89) |
| Product NDC | 0245-0422 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Fentanyl |
| Dosage Form Name | PATCH, EXTENDED RELEASE |
| Route Name | TRANSDERMAL |
| Start Marketing Date | 20130301 |
| Marketing Category Name | ANDA |
| Labeler Name | Upsher-Smith Laboratories, Inc. |
| Substance Name | FENTANYL |
| Strength Number | 75 |
| Strength Unit | ug/h |
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |