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OPANA ER
OPANA ER - 21695-948-60 - (Oxymorphone Hydrochloride)
Drug Information of OPANA ER
| Product NDC: | 21695-948 |
| Proprietary Name: | OPANA ER |
| Non Proprietary Name: | Oxymorphone Hydrochloride |
| Active Ingredient(s): | 5 mg/1 & nbsp; Oxymorphone Hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of OPANA ER
| Product NDC: | 21695-948 |
| Labeler Name: | Rebel Distributors Corp |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021610 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20060622 |
Package Information of OPANA ER
| Package NDC: | 21695-948-60 |
| Package Description: | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (21695-948-60) |
NDC Information of OPANA ER
| NDC Code | 21695-948-60 |
| Proprietary Name | OPANA ER |
| Package Description | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (21695-948-60) |
| Product NDC | 21695-948 |
| 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 | 20060622 |
| Marketing Category Name | NDA |
| Labeler Name | Rebel Distributors Corp |
| Substance Name | OXYMORPHONE HYDROCHLORIDE |
| Strength Number | 5 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
