Product NDC: | 63481-907 |
Proprietary Name: | OPANA |
Non Proprietary Name: | Oxymorphone Hydrochloride |
Active Ingredient(s): | 5 mg/1 & nbsp; Oxymorphone Hydrochloride |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 63481-907 |
Labeler Name: | Endo Pharmaceuticals |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021610 |
Marketing Category: | NDA |
Start Marketing Date: | 20060630 |
Package NDC: | 63481-907-75 |
Package Description: | 5 BLISTER PACK in 1 BOX, UNIT-DOSE (63481-907-75) > 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
NDC Code | 63481-907-75 |
Proprietary Name | OPANA |
Package Description | 5 BLISTER PACK in 1 BOX, UNIT-DOSE (63481-907-75) > 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
Product NDC | 63481-907 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Oxymorphone Hydrochloride |
Dosage Form Name | TABLET, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20060630 |
Marketing Category Name | NDA |
Labeler Name | Endo Pharmaceuticals |
Substance Name | OXYMORPHONE HYDROCHLORIDE |
Strength Number | 5 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |