Product NDC: | 52584-463 |
Proprietary Name: | Nalbuphine Hydrochloride |
Non Proprietary Name: | Nalbuphine Hydrochloride |
Active Ingredient(s): | 10 mg/mL & nbsp; Nalbuphine Hydrochloride |
Administration Route(s): | INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS |
Dosage Form(s): | INJECTION, SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 52584-463 |
Labeler Name: | General Injectables & Vaccines, Inc |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA070914 |
Marketing Category: | ANDA |
Start Marketing Date: | 20100301 |
Package NDC: | 52584-463-01 |
Package Description: | 1 AMPULE in 1 BAG (52584-463-01) > 1 mL in 1 AMPULE |
NDC Code | 52584-463-01 |
Proprietary Name | Nalbuphine Hydrochloride |
Package Description | 1 AMPULE in 1 BAG (52584-463-01) > 1 mL in 1 AMPULE |
Product NDC | 52584-463 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Nalbuphine Hydrochloride |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS |
Start Marketing Date | 20100301 |
Marketing Category Name | ANDA |
Labeler Name | General Injectables & Vaccines, Inc |
Substance Name | NALBUPHINE HYDROCHLORIDE |
Strength Number | 10 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] |