| Product NDC: | 0054-0264 |
| Proprietary Name: | Hydromorphone Hydrochloride |
| Non Proprietary Name: | hydromorphone hydrochloride |
| Active Ingredient(s): | 4 mg/1 & nbsp; hydromorphone hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0054-0264 |
| Labeler Name: | Roxane Laboratories, Inc |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA074597 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20090729 |
| Package NDC: | 0054-0264-24 |
| Package Description: | 4 CONTAINER in 1 CARTON (0054-0264-24) > 25 TABLET in 1 CONTAINER |
| NDC Code | 0054-0264-24 |
| Proprietary Name | Hydromorphone Hydrochloride |
| Package Description | 4 CONTAINER in 1 CARTON (0054-0264-24) > 25 TABLET in 1 CONTAINER |
| Product NDC | 0054-0264 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | hydromorphone hydrochloride |
| Dosage Form Name | TABLET |
| Route Name | ORAL |
| Start Marketing Date | 20090729 |
| Marketing Category Name | ANDA |
| Labeler Name | Roxane Laboratories, Inc |
| Substance Name | HYDROMORPHONE HYDROCHLORIDE |
| Strength Number | 4 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |