Prescription drug · ANDA
Rocuronium NDC 66794-229
Rocuronium bromide 100 mg/10mL · Injection, Solution · Intravenous · Piramal Critical Care Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66794-229-41 | 6679402294166794022941 | 10 VIAL in 1 CARTON (66794-229-41) / 10 mL in 1 VIAL (66794-229-02)Marketed from Jul 20, 2020 |
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
- Active ingredients
- Rocuronium bromide — 100 mg/10mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Piramal Critical Care IncNDC labeler code 66794
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210437
- Marketing start
- Listing expires
- Other FDA classes
- Neuromuscular Nondepolarizing Blockade (Physiologic effect)
- Identifiers
- Product ID 66794-229_3f9e12e4-d3c5-fba6-e063-6294a90a7fd6SPL ID 3f9e12e4-d3c5-fba6-e063-6294a90a7fd6SPL set ID 98255b70-51f9-8d16-e053-2995a90a8f97RxCUI 1234995UNII I65MW4OFHZUPC 0366794228021
- 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
N466794022941followed by a unit qualifier and the quantityPackage 66794-0229-41. 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 66794-229
- What is NDC 66794-229?
- 66794-229 is the product NDC for Rocuronium, Rocuronium bromide 100 mg/10mL injection, solution, listed with the FDA by Piramal Critical Care Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rocuronium.
- What is the active ingredient?
- Rocuronium bromide.
- Who is the labeler?
- Piramal Critical Care Inc, NDC labeler code 66794. 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 | Medical Purchasing Solutions, LLC. | 71872-7349 | 71872-7349-01 |
Other NDCs under ANDA 210437
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 |
|---|---|---|---|---|
| Rocuronium | Rocuronium bromide 50 mg/5mL | Injection, SolutionIntravenous | Piramal Critical Care Inc | 66794-228 |
| Rocuronium | Rocuronium bromide 100 mg/10mL | Injection, SolutionIntravenous | Medical Purchasing Solutions, LLC. | 71872-7349 |
| Rocuronium | Rocuronium bromide 50 mg/5mL | Injection, SolutionIntravenous | Bryant Ranch Prepack | 72162-2263 |