Dexmedetomidine Hydrochloride NDC 0338-9555

NDC codes

FDA NDC Directory

Product NDC (as listed)0338-9555Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00338-9555Add 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
0338-9555-24	00338955524	24 BAG in 1 CARTON (0338-9555-24) / 50 mL in 1 BAGMarketed from Aug 21, 2018

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 200 ug/50mL
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 21, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)General Anesthesia (Physiologic effect)
Identifiers: Product ID 0338-9555_b0c58177-78bb-4d02-8165-e0fc97b98b5eSPL ID b0c58177-78bb-4d02-8165-e0fc97b98b5e
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

N400338955524 followed by a unit qualifier and the quantity

Package 00338-9555-24. 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

The FDA listing for this product does not reference a label (SPL) set.

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 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
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 400 ug/100mL	InjectionIntravenous	Baxter Healthcare Company	43066-565