Prescription drug · ANDA
Rocuronium Bromide NDC 43066-013
Rocuronium bromide 100 mg/10mL · Injection · Intravenous · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43066-013-10 | 43066001310 | 10 VIAL in 1 CARTON (43066-013-10) / 10 mL in 1 VIALMarketed from Jul 15, 2019 |
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 Bromide
- Generic name (nonproprietary)
- rocuronium bromide
- Active ingredients
- Rocuronium bromide — 100 mg/10mL
- Dosage form
- Injection
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091115
- Marketing start
- Listing expires
- Other FDA classes
- Neuromuscular Nondepolarizing Blockade (Physiologic effect)
- Identifiers
- Product ID 43066-013_9e0317de-2d78-4fd8-8926-4c7b476f3ed4SPL ID 9e0317de-2d78-4fd8-8926-4c7b476f3ed4SPL set ID 31e15c3f-aefa-4379-b684-7707744fe40dRxCUI 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
N443066001310followed by a unit qualifier and the quantityPackage 43066-0013-10. 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 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 091115
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 Bromide | Rocuronium bromide 50 mg/5mL | InjectionIntravenous | Medical Purchasing Solutions, LLC | 71872-7262 |
| Rocuronium Bromide | Rocuronium bromide 50 mg/5mL | InjectionIntravenous | Baxter Healthcare Corporation | 43066-007 |
| rocuronium bromide | Rocuronium bromide 10 mg/mL | SolutionIntravenous | Medical Purchasing Solutions, LLC | 71872-7309 |
| rocuronium bromide | Rocuronium bromide 10 mg/mL | SolutionIntravenous | XGen Pharmaceuticals DJB, Inc. | 39822-4200 |
| rocuronium bromide | Rocuronium bromide 10 mg/mL | SolutionIntravenous | Medical Purchasing Solutions, LLC | 71872-7036 |