Product NDC: | 0054-0386 |
Proprietary Name: | Hydromorphone Hydrochloride |
Non Proprietary Name: | hydromorphone hydrochloride |
Active Ingredient(s): | 1 mg/mL & nbsp; hydromorphone hydrochloride |
Administration Route(s): | ORAL |
Dosage Form(s): | SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0054-0386 |
Labeler Name: | Roxane Laboratories, Inc |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA074653 |
Marketing Category: | ANDA |
Start Marketing Date: | 20120301 |
Package NDC: | 0054-0386-63 |
Package Description: | 473 mL in 1 BOTTLE (0054-0386-63) |
NDC Code | 0054-0386-63 |
Proprietary Name | Hydromorphone Hydrochloride |
Package Description | 473 mL in 1 BOTTLE (0054-0386-63) |
Product NDC | 0054-0386 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | hydromorphone hydrochloride |
Dosage Form Name | SOLUTION |
Route Name | ORAL |
Start Marketing Date | 20120301 |
Marketing Category Name | ANDA |
Labeler Name | Roxane Laboratories, Inc |
Substance Name | HYDROMORPHONE HYDROCHLORIDE |
Strength Number | 1 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |