| Product NDC: | 42858-304 |
| Proprietary Name: | Hydromorphone Hydrochloride |
| Non Proprietary Name: | Hydromorphone Hydrochloride |
| Active Ingredient(s): | 5 mg/5mL & nbsp; Hydromorphone Hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 42858-304 |
| Labeler Name: | Rhodes Pharmaceuticals L.P. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA019891 |
| Marketing Category: | NDA AUTHORIZED GENERIC |
| Start Marketing Date: | 20121001 |
| Package NDC: | 42858-304-16 |
| Package Description: | 473 mL in 1 BOTTLE, GLASS (42858-304-16) |
| NDC Code | 42858-304-16 |
| Proprietary Name | Hydromorphone Hydrochloride |
| Package Description | 473 mL in 1 BOTTLE, GLASS (42858-304-16) |
| Product NDC | 42858-304 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Hydromorphone Hydrochloride |
| Dosage Form Name | SOLUTION |
| Route Name | ORAL |
| Start Marketing Date | 20121001 |
| Marketing Category Name | NDA AUTHORIZED GENERIC |
| Labeler Name | Rhodes Pharmaceuticals L.P. |
| Substance Name | HYDROMORPHONE HYDROCHLORIDE |
| Strength Number | 5 |
| Strength Unit | mg/5mL |
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |