Rocuronium Bromide NDC 42677-309

NDC codes

FDA NDC Directory

Product NDC (as listed)42677-309Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42677-0309Add 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
42677-309-10	42677030910	10 VIAL, MULTI-DOSE in 1 CARTON (42677-309-10) / 5 mL in 1 VIAL, MULTI-DOSE (42677-309-01)Marketed from Jul 12, 2024

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, Solution
Route: Intravenous
Labeler: Shandong New Time Pharmaceutical Co., Ltd.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215684
Marketing start: Jul 12, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Neuromuscular Nondepolarizing Blockade (Physiologic effect)
Identifiers: Product ID 42677-309_57d0a65e-ef04-87e6-e063-6294a90a79e1SPL ID 57d0a65e-ef04-87e6-e063-6294a90a79e1SPL set ID f9f66e17-4850-47b6-bb2c-b9d126dffa68RxCUI 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.

How CPT relates to drug billing

NDC on a medical claim

N442677030910 followed by a unit qualifier and the quantity

Package 42677-0309-10. 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 Jul 30, 2026.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 215684

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

FDA NDC Directory listings under ANDA 215684
Product	Strength	Form · route	Labeler	Product NDC
Rocuronium Bromide	Rocuronium bromide 100 mg/10mL	Injection, SolutionIntravenous	Shandong New Time Pharmaceutical Co., Ltd.	42677-310