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NDC 63323-0426-15 Rocuronium 10 mg/mL Details
Rocuronium 10 mg/mL
Rocuronium is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is ROCURONIUM BROMIDE.
Product Information
| NDC | 63323-0426 |
|---|---|
| Product ID | 63323-426_d6e2ff8d-838d-4c27-8e73-230548b09d63 |
| Associated GPIs | 74200047102030 74200047102020 |
| GCN Sequence Number | 021727 |
| GCN Sequence Number Description | rocuronium bromide VIAL 10 MG/ML INTRAVEN |
| HIC3 | S7A |
| HIC3 Description | NEUROMUSCULAR BLOCKING AGENTS |
| GCN | 37201 |
| HICL Sequence Number | 008963 |
| HICL Sequence Number Description | ROCURONIUM BROMIDE |
| Brand/Generic | Generic |
| Proprietary Name | Rocuronium |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ROCURONIUM BROMIDE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/mL |
| Substance Name | ROCURONIUM BROMIDE |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA078651 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63323-0426-15 (63323042615)
| NDC Package Code | 63323-426-15 |
|---|---|
| Billing NDC | 63323042615 |
| Package | 10 VIAL in 1 TRAY (63323-426-15) / 5 mL in 1 VIAL (63323-426-12) |
| Marketing Start Date | 2009-12-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |