Dexmedetomidine Hydrochloride NDC 68083-239

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-239Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0239Add 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
68083-239-10	68083023910	10 VIAL in 1 CARTON (68083-239-10) / 100 mL in 1 VIALMarketed from Jun 3, 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): Dexmedetomidine Hydrochloride
Generic name (nonproprietary): dexmedetomidine hydrochloride
Active ingredients: Dexmedetomidine hydrochloride — 4 ug/mL
Dosage form: Injection
Route: Intravenous
Labeler: Gland Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209307
Marketing start: Jun 3, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)General Anesthesia (Physiologic effect)
Identifiers: Product ID 68083-239_29930c5a-6908-4686-aa11-1560abca3c7fSPL ID 29930c5a-6908-4686-aa11-1560abca3c7fSPL set ID f307de7e-a9ab-4734-abb7-66b4e112bc51RxCUI 1718906, 1718909UNII 1018WH7F9IUPC 0368083239015
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

N468083023910 followed by a unit qualifier and the quantity

Package 68083-0239-10. 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 May 20, 2026.

Indications (excerpt from the label)

Dexmedetomidine hydrochloride in 0.9% sodium chloride 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 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 chlorid…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209307

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

FDA NDC Directory listings under ANDA 209307
Product	Strength	Form · route	Labeler	Product NDC
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 4 ug/mL	Injection, SolutionIntravenous	Dr.Reddy's Laboratories Inc	43598-976
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 4 ug/mL	InjectionIntravenous	Gland Pharma Limited	68083-238
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 4 ug/mL	Injection, SolutionIntravenous	Dr.Reddy's Laboratories Inc	43598-975
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 4 ug/mL	InjectionIntravenous	Sagent Pharmaceuticals	25021-617
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 4 ug/mL	InjectionIntravenous	Piramal Critical Care Inc	66794-234
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 4 ug/mL	InjectionIntravenous	Piramal Critical Care Inc	66794-235
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 4 ug/mL	InjectionIntravenous	Gland Pharma Limited	68083-657