Product NDC: | 52959-549 |
Proprietary Name: | Transmucosal Fentanyl Citrate |
Non Proprietary Name: | fentanyl citrate |
Active Ingredient(s): | 400 ug/1 & nbsp; fentanyl citrate |
Administration Route(s): | ORAL; TRANSMUCOSAL |
Dosage Form(s): | LOZENGE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 52959-549 |
Labeler Name: | H.J. Harkins Company, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA020747 |
Marketing Category: | NDA |
Start Marketing Date: | 20060906 |
Package NDC: | 52959-549-30 |
Package Description: | 30 BLISTER PACK in 1 CARTON (52959-549-30) > 1 LOZENGE in 1 BLISTER PACK (52959-549-01) |
NDC Code | 52959-549-30 |
Proprietary Name | Transmucosal Fentanyl Citrate |
Package Description | 30 BLISTER PACK in 1 CARTON (52959-549-30) > 1 LOZENGE in 1 BLISTER PACK (52959-549-01) |
Product NDC | 52959-549 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | fentanyl citrate |
Dosage Form Name | LOZENGE |
Route Name | ORAL; TRANSMUCOSAL |
Start Marketing Date | 20060906 |
Marketing Category Name | NDA |
Labeler Name | H.J. Harkins Company, Inc. |
Substance Name | FENTANYL CITRATE |
Strength Number | 400 |
Strength Unit | ug/1 |
Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |