| NDC Code | 63323-851-15 |
|---|
| Package Description | 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-851-15) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-851-07) |
|---|
| Product NDC | 63323-851 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Hydromorphone Hydrochloride |
|---|
| Non-Proprietary Name | Hydromorphone Hydrochloride |
|---|
| Dosage Form | INJECTION, SOLUTION |
|---|
| Usage | INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS |
|---|
| Start Marketing Date | 20171215 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA019034 |
|---|
| Manufacturer | Fresenius Kabi USA, LLC |
|---|
| Substance Name | HYDROMORPHONE HYDROCHLORIDE |
|---|
| Strength | 10 |
|---|
| Strength Unit | mg/mL |
|---|
| Pharmacy Classes | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
|---|
| DEA Schedule | CII |
|---|