Prescription drug · ANDA
Rocuronium NDC 72162-2263
Rocuronium bromide 50 mg/5mL · Injection, Solution · Intravenous · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2263-2 | 72162226302 | 10 VIAL in 1 CARTON (72162-2263-2) / 5 mL in 1 VIALMarketed from Feb 23, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 50 mg/5mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Bryant Ranch Prepack
- 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 72162-2263_d6b8655a-04b5-46af-a453-0bf3fa8b8b25SPL ID d6b8655a-04b5-46af-a453-0bf3fa8b8b25SPL set ID 6045ed5a-5d2c-4f17-aaba-458fbf87e85cRxCUI 1234995UNII I65MW4OFHZ
- 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
N472162226302followed by a unit qualifier and the quantityPackage 72162-2263-02. 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.
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 100 mg/10mL | Injection, SolutionIntravenous | Medical Purchasing Solutions, LLC. | 71872-7349 |
| Rocuronium | Rocuronium bromide 50 mg/5mL | Injection, SolutionIntravenous | Piramal Critical Care Inc | 66794-228 |
| Rocuronium | Rocuronium bromide 100 mg/10mL | Injection, SolutionIntravenous | Piramal Critical Care Inc | 66794-229 |