Prescription drug · ANDA
Cisatracurium Besylate NDC 83634-655
Cisatracurium besylate 10 mg/mL · Injection, Solution · Intravenous · Avenacy, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83634-655-20 | 8363406552083634065520 | 10 VIAL, SINGLE-DOSE in 1 CARTON (83634-655-20) / 20 mL in 1 VIAL, SINGLE-DOSE (83634-655-41)Marketed from Aug 15, 2026 |
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, Solution
- Route
- Intravenous
- Labeler
- Avenacy, LLCNDC labeler code 83634
- 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 83634-655_53f69aa3-898e-476d-b18c-573487371a10SPL ID 53f69aa3-898e-476d-b18c-573487371a10SPL set ID 1c6a8b98-deac-4e25-b4a0-5d0af5090281RxCUI 199212UNII 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
N483634065520followed by a unit qualifier and the quantityPackage 83634-0655-20. 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 Cisatracurium Besylate Injection is a nondepolarizing neuromuscular blocker indicated: as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age ( 1 ) to provide skeletal muscle relaxation during surgery in a…
Excerpt only. Read the full label for complete information.
About NDC 83634-655
- What is NDC 83634-655?
- 83634-655 is the product NDC for Cisatracurium Besylate, Cisatracurium besylate 10 mg/mL injection, solution, listed with the FDA by Avenacy, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cisatracurium Besylate.
- What is the active ingredient?
- Cisatracurium besylate.
- Who is the labeler?
- Avenacy, LLC, NDC labeler code 83634. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cisatracurium Besylate?
- 34 other product NDCs are listed under this name. See all Cisatracurium Besylate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cisatracurium Besylate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cisatracurium Besylate | Cisatracurium besylate 10 mg/mL | InjectionIntravenous | Camber Pharmaceuticals Inc. | 31722-312 | 31722-0312-10 |
| Cisatracurium Besylate | Cisatracurium besylate 2 mg/mL | InjectionIntravenous | Camber Pharmaceuticals Inc. | 31722-313 | 31722-0313-10 |
| Cisatracurium Besylate | Cisatracurium besylate 2 mg/mL | InjectionIntravenous | Camber Pharmaceuticals Inc. | 31722-314 | 31722-0314-10 |
| Cisatracurium besylate | Cisatracurium besylate 2 mg/mL | InjectionIntravenous | Gland Pharma Limited | 68083-486 | 68083-0486-01 |
| Cisatracurium besylate | Cisatracurium besylate 10 mg/mL | InjectionIntravenous | Gland Pharma Limited | 68083-487 | 68083-0487-01 |
| Cisatracurium besylate | Cisatracurium besylate 2 mg/mL | InjectionIntravenous | Gland Pharma Limited | 68083-488 | 68083-0488-01 |
| Cisatracurium Besylate | Cisatracurium besylate 10 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9160 | 00143-9160-10 |
| Cisatracurium Besylate | Cisatracurium besylate 2 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9397 | 00143-9397-10 |
| Cisatracurium besylate | Cisatracurium besylate 2 mg/mL | InjectionIntravenous | Caplin Steriles Limited | 65145-135 | 65145-0135-0165145-0135-10 |
| Cisatracurium besylate | Cisatracurium besylate 2 mg/mL | InjectionIntravenous | Caplin Steriles Limited | 65145-136 | 65145-0136-0165145-0136-10 |
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 2 mg/mL | InjectionIntravenous | Slate Run Pharmaceuticals, LLC | 70436-112 |
| Cisatracurium besylate | Cisatracurium besylate 10 mg/mL | InjectionIntravenous | Slate Run Pharmaceuticals, LLC | 70436-114 |