Dexmedetomidine Hydrochloride NDC 43066-565

NDC codes

FDA NDC Directory

Product NDC (as listed)43066-565Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43066-0565Add 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
43066-565-12	43066056512	12 BAG in 1 CARTON (43066-565-12) / 100 mL in 1 BAGMarketed from Aug 27, 2019

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 Hydrochloride
Generic name (nonproprietary): dexmedetomidine hydrochloride
Active ingredients: Dexmedetomidine hydrochloride — 400 ug/100mL
Dosage form: Injection
Route: Intravenous
Labeler: Baxter Healthcare Company
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208532
Marketing start: Aug 27, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)General Anesthesia (Physiologic effect)
Identifiers: Product ID 43066-565_18385e15-6a52-4aec-b152-1cc136179bf4SPL ID 18385e15-6a52-4aec-b152-1cc136179bf4SPL set ID 32242f34-6e2b-4098-bd8e-3d55162f31b5RxCUI 1718906, 1718909UNII 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

N443066056512 followed by a unit qualifier and the quantity

Package 43066-0565-12. 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 Dec 19, 2025.

Indications (excerpt from the label)

Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is an 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 hydrochloride in 0.9% sodium chloride 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) • Sedation of non-intubated pediatric patients aged 1 month to less than 18 years prior to and during non-invasive procedures. ( 1.2 ) 1.1 Intensive Care Unit Sedation Dexmedetomidine hydrochloride in 0.9% sodium chloride…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 208532

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

FDA NDC Directory listings under ANDA 208532
Product	Strength	Form · route	Labeler	Product NDC
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 200 ug/50mL	InjectionIntravenous	Baxter Healthcare Company	0338-9555
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 400 ug/100mL	InjectionIntravenous	Baxter Healthcare Company	0338-9557
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 200 ug/50mL	InjectionIntravenous	Baxter Healthcare Company	43066-561
Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride	Dexmedetomidine hydrochloride 200 ug/50mL	InjectionIntravenous	Baxter Healthcare Company	43066-555
Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride	Dexmedetomidine hydrochloride 400 ug/100mL	InjectionIntravenous	Baxter Healthcare Company	43066-557