Prescription drug · ANDA
Rocuronium (Rocuronium bromide) NDC 63323-426
Rocuronium bromide 10 mg/mL · Injection, Solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-426-05 | 6332304260563323042605 | 10 VIAL in 1 TRAY (63323-426-05) / 5 mL in 1 VIAL (63323-426-02)Marketed from Dec 13, 2009 | |
| 63323-426-10 | 6332304261063323042610 | 10 VIAL in 1 TRAY (63323-426-10) / 10 mL in 1 VIAL (63323-426-01)Marketed from Dec 13, 2009 |
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)
- Rocuronium
- Generic name (nonproprietary)
- rocuronium bromide
- Active ingredients
- Rocuronium bromide — 10 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078651
- Marketing start
- Listing expires
- Other FDA classes
- Neuromuscular Nondepolarizing Blockade (Physiologic effect)
- Identifiers
- Product ID 63323-426_d6e2ff8d-838d-4c27-8e73-230548b09d63SPL ID d6e2ff8d-838d-4c27-8e73-230548b09d63SPL set ID f1933332-1ae0-4dc1-be4c-694849e6c9f9RxCUI 1234995UNII I65MW4OFHZUPC 0363323426019, 0363323426026
- 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
N463323042605followed by a unit qualifier and the quantityPackage 63323-0426-05. 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)
Rocuronium Bromide Injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Rocuronium Bromide Injection is a nondepolarizing neuromuscular blocking agent indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 63323-426
- What is NDC 63323-426?
- 63323-426 is the product NDC for Rocuronium (rocuronium bromide), Rocuronium bromide 10 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rocuronium (Rocuronium bromide).
- What is the active ingredient?
- Rocuronium bromide.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rocuronium?
- 12 other product NDCs are listed under this name. See all Rocuronium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rocuronium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Rocuroniumrocuronium bromide | Rocuronium bromide 10 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 65219-442 | 65219-0442-05 |
| Rocuroniumrocuronium bromide | Rocuronium bromide 10 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 65219-444 | 65219-0444-10 |
| Rocuroniumrocuronium bromide | Rocuronium bromide 10 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 65219-695 | 65219-0695-05 |
| Rocuroniumrocuronium bromide | Rocuronium bromide 10 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 65219-697 | 65219-0697-10 |
| Rocuroniumrocuronium bromide | Rocuronium bromide 10 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 76045-220 | 76045-0220-50 |
| Rocuroniumrocuronium bromide | Rocuronium bromide 10 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 76045-221 | 76045-0221-50 |
| Rocuroniumrocuronium bromide | Rocuronium bromide 10 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 65219-065 | 65219-0065-05 |
| Rocuroniumrocuronium bromide | Rocuronium bromide 10 mg/mL | Injection, SolutionIntravenous | Phlow Corporation | 81565-204 | 81565-0204-02 |
| Rocuronium | Rocuronium bromide 50 mg/5mL | Injection, SolutionIntravenous | Piramal Critical Care Inc | 66794-228 | 66794-0228-41 |
| Rocuronium | Rocuronium bromide 100 mg/10mL | Injection, SolutionIntravenous | Piramal Critical Care Inc | 66794-229 | 66794-0229-41 |
Other NDCs under ANDA 078651
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 |
|---|---|---|---|---|
| Rocuroniumrocuronium bromide | Rocuronium bromide 10 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 65219-065 |
| Rocuroniumrocuronium bromide | Rocuronium bromide 10 mg/mL | Injection, SolutionIntravenous | Phlow Corporation | 81565-204 |