Dexmedetomidine NDC 68083-527

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-527Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0527Add 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
68083-527-25	68083052725	25 VIAL in 1 CARTON (68083-527-25) / 2 mL in 1 VIALMarketed from Jun 28, 2021

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: Gland Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202126
Marketing start: Jun 28, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)General Anesthesia (Physiologic effect)
Identifiers: Product ID 68083-527_daec1549-17b5-483b-8efe-55b936be5174SPL ID daec1549-17b5-483b-8efe-55b936be5174SPL set ID 714cc0d2-8a4c-40c0-8ef0-dcfde4c46989RxCUI 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

N468083052725 followed by a unit qualifier and the quantity

Package 68083-0527-25. 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

Current FDA label (SPL), effective May 19, 2026.

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 ) • 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 injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during tre…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202126

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

FDA NDC Directory listings under ANDA 202126
Product	Strength	Form · route	Labeler	Product NDC
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 100 ug/mL	Injection, SolutionIntravenous	Medical Purchasing Solutions, LLC	71872-7122
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 100 ug/mL	Injection, SolutionIntravenous	Sun Pharmaceuticals Industries, Inc.	57664-596
Dexmedetomidine	Dexmedetomidine hydrochloride 200 ug/2mL	Injection, SolutionIntravenous	Piramal Critical Care Inc	66794-230
Dexmedetomidine	Dexmedetomidine hydrochloride 200 ug/2mL	Injection, SolutionIntravenous	Piramal Critical Care Inc	66794-233
Dexmedetomidine	Dexmedetomidine hydrochloride 200 ug/2mL	Injection, SolutionIntravenous	ProPharma Distribution	84549-230
Dexmedetomidine	Dexmedetomidine hydrochloride 200 ug/2mL	Injection, SolutionIntravenous	Medical Purchasing Solutions, LLC	71872-7323