Dexmedetomidine NDC 84549-505

NDC codes

FDA NDC Directory

Product NDC (as listed)84549-505Labeler and product segments. Claims need a package NDC.

Product NDC at billing width84549-0505Add 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
84549-505-03	84549050503	2 mL in 1 VIAL, SINGLE-DOSE (84549-505-03)Marketed from Oct 10, 2025

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): Dexmedetomidine
Generic name (nonproprietary): dexmedetomidine
Active ingredients: Dexmedetomidine hydrochloride — 100 ug/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: ProPharma Distribution
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204843
Marketing start: Jan 18, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)General Anesthesia (Physiologic effect)
Identifiers: Product ID 84549-505_42dab90e-68c2-bed1-e063-6294a90a4b0cSPL ID 42dab90e-68c2-bed1-e063-6294a90a4b0cSPL set ID 42dab90e-68c1-bed1-e063-6294a90a4b0cRxCUI 309710UNII 1018WH7F9I
Pharmacologic class: Central alpha-2 Adrenergic 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

N484549050503 followed by a unit qualifier and the quantity

Package 84549-0505-03. 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 Nov 5, 2025.

Indications (excerpt from the label)

Dexmedetomidine Injection is a alpha 2 -adrenergic receptor agonist indicated for: Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer Dexmedetomidine Injection by continuous infusion not to exceed 24 hours. ( 1.1 ) Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. ( 1.2 ) 1.1 Intensive Care Unit Sedation Dexmedetomidine Injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Dexmedetomidine Injection should be administered by continuous infusion not to exceed 24 hours. Dexmed…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204843

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

FDA NDC Directory listings under ANDA 204843
Product	Strength	Form · route	Labeler	Product NDC
Dexmedetomidine	Dexmedetomidine hydrochloride 100 ug/mL	Injection, SolutionIntravenous	Meitheal Pharmaceuticals Inc.	71288-505