Rocuronium (rocuronium bromide) NDC 81565-204

NDC codes

FDA NDC Directory

Product NDC (as listed)81565-204Labeler and product segments. Claims need a package NDC.

Product NDC at billing width81565-0204Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
81565-204-02	81565020402	10 VIAL in 1 TRAY (81565-204-02) / 5 mL in 1 VIAL (81565-204-01)Marketed from Feb 8, 2022

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: Phlow Corporation
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078651
Marketing start: Feb 8, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Neuromuscular Nondepolarizing Blockade (Physiologic effect)
Identifiers: Product ID 81565-204_7297a261-1b67-4281-bd1d-80a366cb446eSPL ID 7297a261-1b67-4281-bd1d-80a366cb446eSPL set ID ad34ecc7-ff1f-4ee5-a235-e453873d0313RxCUI 1234995UNII I65MW4OFHZUPC 0381565204011
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.

How CPT relates to drug billing

NDC on a medical claim

N481565020402 followed by a unit qualifier and the quantity

Package 81565-0204-02. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 078651

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078651
Product	Strength	Form · route	Labeler	Product NDC
Rocuroniumrocuronium bromide	Rocuronium bromide 10 mg/mL	Injection, SolutionIntravenous	Fresenius Kabi USA, LLC	63323-426
Rocuroniumrocuronium bromide	Rocuronium bromide 10 mg/mL	Injection, SolutionIntravenous	Fresenius Kabi USA, LLC	63323-426
Rocuroniumrocuronium bromide	Rocuronium bromide 10 mg/mL	Injection, SolutionIntravenous	Fresenius Kabi USA, LLC	65219-065