| Product NDC: | 17478-540 |
| Proprietary Name: | Hydromorphone Hydrochloride |
| Non Proprietary Name: | Hydromorphone Hydrochloride |
| Active Ingredient(s): | 10 mg/mL & nbsp; Hydromorphone Hydrochloride |
| Administration Route(s): | PARENTERAL |
| Dosage Form(s): | INJECTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 17478-540 |
| Labeler Name: | Akorn |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA078228 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20100515 |
| Package NDC: | 17478-540-01 |
| Package Description: | 10 AMPULE in 1 CARTON (17478-540-01) > 1 mL in 1 AMPULE |
| NDC Code | 17478-540-01 |
| Proprietary Name | Hydromorphone Hydrochloride |
| Package Description | 10 AMPULE in 1 CARTON (17478-540-01) > 1 mL in 1 AMPULE |
| Product NDC | 17478-540 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Hydromorphone Hydrochloride |
| Dosage Form Name | INJECTION |
| Route Name | PARENTERAL |
| Start Marketing Date | 20100515 |
| Marketing Category Name | ANDA |
| Labeler Name | Akorn |
| Substance Name | HYDROMORPHONE HYDROCHLORIDE |
| Strength Number | 10 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |