Product NDC: | 63481-812 |
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: | 63481-812 |
Labeler Name: | Endo Pharmaceuticals Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA201655 |
Marketing Category: | NDA |
Start Marketing Date: | 20120320 |
Package NDC: | 63481-812-20 |
Package Description: | 2 BLISTER PACK in 1 BOX, UNIT-DOSE (63481-812-20) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
NDC Code | 63481-812-20 |
Proprietary Name | Opana |
Package Description | 2 BLISTER PACK in 1 BOX, UNIT-DOSE (63481-812-20) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
Product NDC | 63481-812 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | oxymorphone hydrochloride |
Dosage Form Name | TABLET, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20120320 |
Marketing Category Name | NDA |
Labeler Name | Endo Pharmaceuticals Inc. |
Substance Name | OXYMORPHONE HYDROCHLORIDE |
Strength Number | 5 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |