| Product NDC: | 54868-0162 |
| Proprietary Name: | Fentanyl |
| Non Proprietary Name: | fentanyl |
| Active Ingredient(s): | 2.55 mg/[USP'U] & nbsp; fentanyl |
| Administration Route(s): | TRANSDERMAL |
| Dosage Form(s): | PATCH |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 54868-0162 |
| Labeler Name: | Physicians Total Care, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA076258 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20050714 |
| Package NDC: | 54868-0162-1 |
| Package Description: | 10 POUCH in 1 CARTON (54868-0162-1) > 1 PATCH in 1 POUCH > 72 [USP'U] in 1 PATCH |
| NDC Code | 54868-0162-1 |
| Proprietary Name | Fentanyl |
| Package Description | 10 POUCH in 1 CARTON (54868-0162-1) > 1 PATCH in 1 POUCH > 72 [USP'U] in 1 PATCH |
| Product NDC | 54868-0162 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | fentanyl |
| Dosage Form Name | PATCH |
| Route Name | TRANSDERMAL |
| Start Marketing Date | 20050714 |
| Marketing Category Name | ANDA |
| Labeler Name | Physicians Total Care, Inc. |
| Substance Name | FENTANYL |
| Strength Number | 2.55 |
| Strength Unit | mg/[USP'U] |
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |