| Product NDC: | 16590-942 |
| Proprietary Name: | EXALGO |
| Non Proprietary Name: | HYDROMORPHONE HYDROCHLORIDE |
| Active Ingredient(s): | 8 mg/1 & nbsp; HYDROMORPHONE HYDROCHLORIDE |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 16590-942 |
| Labeler Name: | STAT Rx USA LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021217 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20110314 |
| Package NDC: | 16590-942-90 |
| Package Description: | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (16590-942-90) |
| NDC Code | 16590-942-90 |
| Proprietary Name | EXALGO |
| Package Description | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (16590-942-90) |
| Product NDC | 16590-942 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | HYDROMORPHONE HYDROCHLORIDE |
| Dosage Form Name | TABLET, EXTENDED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20110314 |
| Marketing Category Name | NDA |
| Labeler Name | STAT Rx USA LLC |
| Substance Name | HYDROMORPHONE HYDROCHLORIDE |
| Strength Number | 8 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |