Prescription drug · ANDA
Rocuronium Bromide NDC 43547-530
Rocuronium bromide 50 mg/5mL · Injection · Intravenous · Solco Healthcare US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-530-10 | 4354705301043547053010 | 10 VIAL, MULTI-DOSE in 1 CARTON (43547-530-10) / 5 mL in 1 VIAL, MULTI-DOSE (43547-530-01)Marketed from Jul 25, 2021 |
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 — 50 mg/5mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Solco Healthcare US, LLCNDC labeler code 43547
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212668
- Marketing start
- Listing expires
- Other FDA classes
- Neuromuscular Nondepolarizing Blockade (Physiologic effect)
- Identifiers
- Product ID 43547-530_e926b7a9-5f03-47c4-a7d0-2780b01a34c5SPL ID e926b7a9-5f03-47c4-a7d0-2780b01a34c5SPL set ID b7fba679-9c2d-4dac-af53-8c1331c966c3RxCUI 1234995UNII I65MW4OFHZUPC 0343547530013, 0343547531010
- 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
N443547053010followed by a unit qualifier and the quantityPackage 43547-0530-10. 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 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 43547-530
- What is NDC 43547-530?
- 43547-530 is the product NDC for Rocuronium Bromide, Rocuronium bromide 50 mg/5mL injection, listed with the FDA by Solco Healthcare US, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rocuronium Bromide.
- What is the active ingredient?
- Rocuronium bromide.
- Who is the labeler?
- Solco Healthcare US, LLC, NDC labeler code 43547. 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 Bromide?
- 53 other product NDCs are listed under this name. See all Rocuronium Bromide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rocuronium Bromide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Rocuronium Bromide | Rocuronium bromide 50 mg/5mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 43066-507 | 43066-0507-05 |
| Rocuronium Bromide | Rocuronium bromide 100 mg/10mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 43066-509 | 43066-0509-05 |
| Rocuronium Bromide | Rocuronium bromide 50 mg/5mL | InjectionIntravenous | B. Braun Medical Inc. | 0264-5711 | 00264-5711-10 |
| Rocuronium Bromide | Rocuronium bromide 50 mg/5mL | InjectionIntravenous | Lifestar Pharma LLC | 70756-669 | 70756-0669-1070756-0669-85 |
| Rocuronium Bromide | Rocuronium bromide 100 mg/10mL | InjectionIntravenous | Lifestar Pharma LLC | 70756-670 | 70756-0670-1070756-0670-86 |
| Rocuronium Bromide | Rocuronium bromide 50 mg/5mL | Injection, SolutionIntravenous | STERISCIENCE SPECIALTIES PRIVATE LIMITED | 82449-001 | 82449-0001-02 |
| Rocuronium Bromide | Rocuronium bromide 10 mg/mL | Injection, SolutionIntravenous | Caplin Steriles Limited | 65145-130 | 65145-0130-10 |
| Rocuronium Bromide | Rocuronium bromide 10 mg/mL | Injection, SolutionIntravenous | Caplin Steriles Limited | 65145-131 | 65145-0131-10 |
| Rocuronium Bromide | Rocuronium bromide 10 mg/mL | Injection, SolutionIntravenous | Medical Purchasing Solutions, LLC | 71872-7372 | 71872-7372-01 |
| Rocuronium Bromide | Rocuronium bromide 10 mg/mL | Injection, SolutionIntravenous | ProPharma Distribution | 84549-131 | 84549-0131-10 |
Other NDCs under ANDA 212668
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 100 mg/10mL | InjectionIntravenous | Solco Healthcare US, LLC | 43547-531 |
| Rocuronium Bromide | Rocuronium bromide 100 mg/10mL | InjectionIntravenous | Medical Purchasing Solutions, LLC | 71872-7379 |