Prescription drug · ANDA
Cisatracurium besylate NDC 70436-114
Cisatracurium besylate 10 mg/mL · Injection · Intravenous · Slate Run Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70436-114-82 | 70436011482 | 10 VIAL, SINGLE-DOSE in 1 CARTON (70436-114-82) / 20 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 2, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Cisatracurium besylate
- Generic name (nonproprietary)
- cisatracurium besylate
- Active ingredients
- Cisatracurium besylate — 10 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216539
- Marketing start
- Listing expires
- Other FDA classes
- Neuromuscular Nondepolarizing Blockade (Physiologic effect)
- Identifiers
- Product ID 70436-114_20cd9789-700a-5fa0-e063-6394a90a5d0dSPL ID 20cd9789-700a-5fa0-e063-6394a90a5d0dSPL set ID 49185e78-d244-4426-90ef-ad109824eddbRxCUI 199212, 1730194UNII 80YS8O1MBS
- Pharmacologic class
- Nondepolarizing Neuromuscular Blocker
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N470436011482followed by a unit qualifier and the quantityPackage 70436-0114-82. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Cisatracurium Besylate Injection is indicated: as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older Limitations of Use Cisatracurium Besylate Injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action. Cisatracurium Besylate Injection is a nondepolarizing neuromuscular blocker indicated: as an adjunct to general anesthe…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216539
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cisatracurium Besylate | Cisatracurium besylate 10 mg/mL | Injection, SolutionIntravenous | Avenacy, LLC | 83634-655 |
| Cisatracurium besylate | Cisatracurium besylate 2 mg/mL | InjectionIntravenous | Slate Run Pharmaceuticals, LLC | 70436-112 |