| Product NDC: | 0052-0450 |
| Proprietary Name: | Zemuron |
| Non Proprietary Name: | rocuronium bromide |
| Active Ingredient(s): | 10 mg/mL & nbsp; rocuronium bromide |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0052-0450 |
| Labeler Name: | Organon USA Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020214 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20101122 |
| Package NDC: | 0052-0450-15 |
| Package Description: | 10 VIAL, MULTI-DOSE in 1 CARTON (0052-0450-15) > 5 mL in 1 VIAL, MULTI-DOSE |
| NDC Code | 0052-0450-15 |
| Proprietary Name | Zemuron |
| Package Description | 10 VIAL, MULTI-DOSE in 1 CARTON (0052-0450-15) > 5 mL in 1 VIAL, MULTI-DOSE |
| Product NDC | 0052-0450 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | rocuronium bromide |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20101122 |
| Marketing Category Name | NDA |
| Labeler Name | Organon USA Inc. |
| Substance Name | ROCURONIUM BROMIDE |
| Strength Number | 10 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] |