Prescription drug · ANDA
Cisatracurium besylate NDC 68083-488
Cisatracurium besylate 2 mg/mL · Injection · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-488-01 | 68083048801 | 1 VIAL, MULTI-DOSE in 1 CARTON (68083-488-01) / 10 mL in 1 VIAL, MULTI-DOSEMarketed from Mar 19, 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
- Gland Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215516
- Marketing start
- Listing expires
- Other FDA classes
- Neuromuscular Nondepolarizing Blockade (Physiologic effect)
- Identifiers
- Product ID 68083-488_773f0b75-fafa-439a-b4a3-ca4d2d65eabdSPL ID 773f0b75-fafa-439a-b4a3-ca4d2d65eabdSPL set ID 0bacc37a-5e7f-4f05-9206-56fc8041c1adRxCUI 199211, 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
N468083048801followed by a unit qualifier and the quantityPackage 68083-0488-01. 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 general a…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215516
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 2 mg/mL | InjectionIntravenous | Gland Pharma Limited | 68083-486 |
| Cisatracurium besylate | Cisatracurium besylate 10 mg/mL | InjectionIntravenous | Gland Pharma Limited | 68083-487 |