NDC 0074-4380
Nimbex
Cisatracurium Besylate
Nimbex is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Abbvie Inc.. The primary component is Cisatracurium Besylate.
| Product ID | 0074-4380_11cd3799-876f-1766-e06e-547eadc3c832 |
| NDC | 0074-4380 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Nimbex |
| Generic Name | Cisatracurium Besylate |
| Dosage Form | Injection |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2010-12-09 |
| Marketing Category | NDA / NDA |
| Application Number | NDA020551 |
| Labeler Name | AbbVie Inc. |
| Substance Name | CISATRACURIUM BESYLATE |
| Active Ingredient Strength | 2 mg/mL |
| Pharm Classes | Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 0074-4380-10
10 mL in 1 VIAL, MULTI-DOSE (0074-4380-10)
| Marketing Start Date | 2010-12-09 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0074-4380-10 [00074438010]
Nimbex INJECTION
| Marketing Category | NDA |
| Application Number | NDA020551 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2010-12-09 |
NDC 0074-4380-01 [00074438001]
Nimbex INJECTION
| Marketing Category | NDA |
| Application Number | NDA020551 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-12-09 |
| Marketing End Date | 2010-12-15 |
NDC 0074-4380-81 [00074438081]
Nimbex INJECTION
| Marketing Category | NDA |
| Application Number | NDA020551 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2019-10-31 |
NDC 0074-4380-79 [00074438079]
Nimbex INJECTION
| Marketing Category | NDA |
| Application Number | NDA020551 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2010-12-09 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| CISATRACURIUM BESYLATE | 2 mg/mL |
OpenFDA Data
| SPL SET ID: | 24b9880e-626b-14e7-23a6-4960f1008e97 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Neuromuscular Nondepolarizing Blockade [PE]
- Nondepolarizing Neuromuscular Blocker [EPC]
NDC Crossover Matching brand name "Nimbex" or generic name "Cisatracurium Besylate"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0074-4378 | Nimbex | Cisatracurium besylate |
| 0074-4380 | Nimbex | Cisatracurium besylate |
| 0074-4382 | Nimbex | Cisatracurium besylate |
| 0409-1098 | Cisatracurium Besylate | CISATRACURIUM BESYLATE |
| 0409-1103 | Cisatracurium Besylate | CISATRACURIUM BESYLATE |
Trademark Results [Nimbex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NIMBEX 74500213 2012276 Live/Registered |
GLAXOSMITHKLINE LLC 1994-03-14 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.