Remifentanil Hydrochloride NDC 63323-725

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-725Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0725Add 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
63323-725-10	63323072510	10 VIAL, SINGLE-DOSE in 1 CARTON (63323-725-10) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-725-01)Marketed from Jan 19, 2018

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): Remifentanil Hydrochloride
Generic name (nonproprietary): remifentanil hydrochloride
Active ingredients: Remifentanil hydrochloride — 1 mg/mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Fresenius Kabi USA, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206223
Marketing start: Jan 19, 2018
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 63323-725_2f27e51f-2b55-47ee-bd4a-001b71c60622SPL ID 2f27e51f-2b55-47ee-bd4a-001b71c60622SPL set ID d2374b84-81c9-44f9-a4a9-1071281b2531RxCUI 1729578, 1729584, 1729710UNII 5V444H5WICUPC 0363323725013, 0363323724016, 0363323723019
Pharmacologic class: Opioid Agonist

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

N463323072510 followed by a unit qualifier and the quantity

Package 63323-0725-10. 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 Sep 15, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Remifentanil hydrochloride (HCl) for injection is indicated for intravenous (IV) administration: • As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures. • For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting. • As an analgesic component of monitored anesthesia care in adult patients. Remifentanil hydrochloride for injection is an opioid agonist indicated for intravenous administration: • As an analgesic agent for use during the induction and maintenance of …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206223

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

FDA NDC Directory listings under ANDA 206223
Product	Strength	Form · route	Labeler	Product NDC
Remifentanil Hydrochloride	Remifentanil hydrochloride 1 mg/mL	Injection, Powder, Lyophilized, For solutionIntravenous	Fresenius Kabi USA, LLC	63323-724
Remifentanil Hydrochloride	Remifentanil hydrochloride 1 mg/mL	Injection, Powder, Lyophilized, For solutionIntravenous	Fresenius Kabi USA, LLC	63323-723
Remifentanil Hydrochloride	Remifentanil hydrochloride 1 mg/mL	Injection, Powder, Lyophilized, For solutionIntravenous	Fresenius Kabi USA, LLC	63323-723