Prescription drug · ANDA
Cisatracurium besylate NDC 65145-135
Cisatracurium besylate 2 mg/mL · Injection · Intravenous · Caplin Steriles Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65145-135-01 | 65145013501 | 1 VIAL, SINGLE-USE in 1 CARTON (65145-135-01) / 5 mL in 1 VIAL, SINGLE-USEMarketed from Jan 17, 2025 | |
| 65145-135-10 | 65145013510 | 10 VIAL, SINGLE-USE in 1 CARTON (65145-135-10) / 5 mL in 1 VIAL, SINGLE-USEMarketed from Jan 17, 2025 |
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 — 2 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Caplin Steriles Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217725
- Marketing start
- Listing expires
- Other FDA classes
- Neuromuscular Nondepolarizing Blockade (Physiologic effect)
- Identifiers
- Product ID 65145-135_984769d6-523a-4e06-aaa7-ccbb039e38eaSPL ID 984769d6-523a-4e06-aaa7-ccbb039e38eaSPL set ID 93101770-10a1-4bad-a762-289c793d8aceRxCUI 199211, 199212, 1730194UNII 80YS8O1MBSUPC 0365145135100, 0365145136015, 0365145137012, 0365145135018
- 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
N465145013501followed by a unit qualifier and the quantityPackage 65145-0135-01. 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 genera…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217725
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 | InjectionIntravenous | Caplin Steriles Limited | 65145-137 |
| Cisatracurium besylate | Cisatracurium besylate 2 mg/mL | InjectionIntravenous | Caplin Steriles Limited | 65145-136 |
| Cisatracurium Besylate | Cisatracurium besylate 200 mg/20mL | InjectionIntravenous | Armas Pharmaceuticals | 72485-513 |