Dexmedetomidine HCl NDC 0143-9532

NDC codes

FDA NDC Directory

Product NDC (as listed)0143-9532Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00143-9532Add 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
0143-9532-25	00143953225	25 VIAL in 1 CARTON (0143-9532-25) / 2 mL in 1 VIAL (0143-9532-01)Marketed from Apr 26, 2017

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 HCl
Generic name (nonproprietary): dexmedetomidine hcl
Active ingredients: Dexmedetomidine hydrochloride — 100 ug/mL
Dosage form: Injection
Route: Intravenous
Labeler: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205046
Marketing start: Apr 26, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)General Anesthesia (Physiologic effect)
Identifiers: Product ID 0143-9532_09161c32-f8f5-4846-b9b0-55a712fe7743SPL ID 09161c32-f8f5-4846-b9b0-55a712fe7743
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

N400143953225 followed by a unit qualifier and the quantity

Package 00143-9532-25. 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 205046

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

FDA NDC Directory listings under ANDA 205046
Product	Strength	Form · route	Labeler	Product NDC
Dexmedetomidine HCl	Dexmedetomidine hydrochloride 100 ug/mL	InjectionIntravenous	Medical Purchasing Solutions, LLC	71872-7218