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NDC 72785-0008-06 cisatracurium besylate 2 mg/mL Details
cisatracurium besylate 2 mg/mL
cisatracurium besylate is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Lifesciences Limited. The primary component is CISATRACURIUM BESYLATE.
Product Information
| NDC | 72785-0008 |
|---|---|
| Product ID | 72785-0008_1b257332-a1a5-406e-86e4-283580657dc6 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | cisatracurium besylate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | cisatracurium besylate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 2 |
| Active Ingredient Units | mg/mL |
| Substance Name | CISATRACURIUM BESYLATE |
| Labeler Name | Zydus Lifesciences Limited |
| Pharmaceutical Class | Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA212171 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 72785-0008-06 (72785000806)
| NDC Package Code | 72785-0008-6 |
|---|---|
| Billing NDC | 72785000806 |
| Package | 10 VIAL in 1 CARTON (72785-0008-6) / 5 mL in 1 VIAL (72785-0008-1) |
| Marketing Start Date | 2020-02-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e145a40e-b046-4064-b35e-0da40ff3703e Details
PRINCIPAL DISPLAY PANEL
Principal Display Panel – Container Label (10 mg/5 mL)
NDC 72785-0008-1
Cisatracurium Besylate Injection, USP
10 mg/5 mL*
(2 mg/mL)
WARNING: Paralyzing Agent
For Intravenous Injection
Preservative free
5 mL Single-Dose Vial
Rx only
Zydus Pharmaceuticals
Principal Display Panel – Container Label (200 mg/20 mL)
NDC 72785-0009-1
Cisatracurium Besylate Injection, USP
200 mg/20 mL*
(10 mg/mL)
WARNING: Paralyzing Agent
For ICU use only.
For Intravenous Injection
Preservative free
20 mL Single-Dose Vial
Rx only
Zydus Pharmaceuticals
Principal Display Panel – Carton Label (10 mg/5 mL)
NDC 72785-0008-6
Cisatracurium Besylate Injection, USP
10 mg/5 mL*
(2 mg/mL)
WARNING: Paralyzing Agent
For Intravenous Injection
Preservative free
10 x 5 mL Single-Dose Vials
Rx only
Zydus Pharmaceuticals
Principal Display Panel – Carton Label (200 mg/20 mL)
NDC 72785-0009-6
Cisatracurium Besylate Injection, USP
200 mg/20 mL*
(10 mg/mL)
WARNING: Paralyzing Agent
For ICU use only.
For Intravenous Injection
Preservative free
10 x 20 mL Single-Dose Vials
Rx only
Zydus Pharmaceuticals
INGREDIENTS AND APPEARANCE
| CISATRACURIUM BESYLATE
cisatracurium besylate injection |
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| CISATRACURIUM BESYLATE
cisatracurium besylate injection |
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| Labeler - Zydus Lifesciences Limited (873671928) |