Fentanyl Citrate NDC 63323-808

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-808Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0808Add 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
63323-808-11	63323080811	10 SYRINGE in 1 CARTON (63323-808-11) / 1 mL in 1 SYRINGE (63323-808-01)Marketed from Sep 30, 2020

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): Fentanyl Citrate
Generic name (nonproprietary): fentanyl citrate
Active ingredients: Fentanyl citrate — 50 ug/mL
Dosage form: Injection, Solution
Route: Intramuscular, Intravenous
Labeler: Fresenius Kabi USA, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212086
Marketing start: Sep 30, 2020
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 63323-808_a47a3a31-e293-49d5-b6bc-950303525a64SPL ID a47a3a31-e293-49d5-b6bc-950303525a64SPL set ID 0c10e465-4117-48ba-a454-23ccb7a3fcc7RxCUI 2474267, 2474269UNII MUN5LYG46H
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

N463323080811 followed by a unit qualifier and the quantity

Package 63323-0808-11. 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 24, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Fentanyl Citrate Injection is indicated for: • analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises. • use as a narcotic analgesic supplement in general or regional anesthesia. • administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia. • use as an anesthetic agent with oxygen in selected high-risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures. Fentanyl Citrate Injection is indicated…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212086

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

FDA NDC Directory listings under ANDA 212086
Product	Strength	Form · route	Labeler	Product NDC
Fentanyl Citrate	Fentanyl citrate 100 ug/2mL	Injection, SolutionIntramuscular, Intravenous	Fresenius Kabi USA, LLC	63323-810