Product NDC: | 0115-1232 |
Proprietary Name: | Oxymorphone hydrochloride |
Non Proprietary Name: | Oxymorphone hydrochloride |
Active Ingredient(s): | 10 mg/1 & nbsp; Oxymorphone hydrochloride |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0115-1232 |
Labeler Name: | Global Pharmaceuticals, Division of Impax Laboratories, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA079087 |
Marketing Category: | ANDA |
Start Marketing Date: | 20130102 |
Package NDC: | 0115-1232-08 |
Package Description: | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1232-08) |
NDC Code | 0115-1232-08 |
Proprietary Name | Oxymorphone hydrochloride |
Package Description | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1232-08) |
Product NDC | 0115-1232 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Oxymorphone hydrochloride |
Dosage Form Name | TABLET, FILM COATED, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20130102 |
Marketing Category Name | ANDA |
Labeler Name | Global Pharmaceuticals, Division of Impax Laboratories, Inc. |
Substance Name | OXYMORPHONE HYDROCHLORIDE |
Strength Number | 10 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |