What is NDC 67457-924?

67457-924 is the product NDC for Dexmedetomidine Hydrochloride, Dexmedetomidine hydrochloride 200 ug/50mL injection, solution, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Mylan Institutional LLC, NDC labeler code 67457. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Dexmedetomidine Hydrochloride?

38 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Dexmedetomidine Hydrochloride NDC 67457-924

NDC codes

FDA NDC Directory

Product NDC (as listed)67457-924Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67457-0924Add 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
67457-924-50	6745709245067457092450	20 BOTTLE in 1 CARTON (67457-924-50) / 50 mL in 1 BOTTLE (67457-924-00)Marketed from Nov 13, 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 — 200 ug/50mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Mylan Institutional LLCNDC labeler code 67457
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212571
Marketing start: Nov 13, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)General Anesthesia (Physiologic effect)
Identifiers: Product ID 67457-924_e4cda7fa-dac8-4de7-abc1-d1fd622795d8SPL ID e4cda7fa-dac8-4de7-abc1-d1fd622795d8SPL set ID f140de5a-f13d-46b4-a742-049c63e474f5RxCUI 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

N467457092450 followed by a unit qualifier and the quantity

Package 67457-0924-50. 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 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 chlori…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67457-924

What is NDC 67457-924?: 67457-924 is the product NDC for Dexmedetomidine Hydrochloride, Dexmedetomidine hydrochloride 200 ug/50mL injection, solution, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Dexmedetomidine Hydrochloride.
What is the active ingredient?: Dexmedetomidine hydrochloride.
Who is the labeler?: Mylan Institutional LLC, NDC labeler code 67457. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dexmedetomidine Hydrochloride?: 38 other product NDCs are listed under this name. See all Dexmedetomidine Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Dexmedetomidine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 100 ug/mL	Injection, Solution, ConcentrateIntravenous	Baxter Healthcare Corporation	36000-262	36000-0262-0536000-0262-1036000-0262-25
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 4 ug/mL	Injection, SolutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9198	00143-9198-10
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 4 ug/mL	InjectionIntravenous	Sagent Pharmaceuticals	25021-617	25021-0617-82
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 4 ug/mL	InjectionIntravenous	Wilshire Pharmaceuticals, Inc.	52536-125	52536-0125-10
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 4 ug/mL	InjectionIntravenous	Wilshire Pharmaceuticals, Inc.	52536-126	52536-0126-08
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 4 ug/mL	InjectionIntravenous	Gland Pharma Limited	68083-657	68083-0657-10
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 100 ug/mL	Injection, SolutionIntravenous	Somerset Therapeutics, LLC	70069-758	70069-0758-04
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 100 ug/mL	Injection, SolutionIntravenous	Somerset Therapeutics, LLC	70069-759	70069-0759-04
Dexmedetomidine Hydrochloridedexmedetomidine hydrochloride in sodium chloride	Dexmedetomidine hydrochloride 4 ug/mL	InjectionIntravenous	Amneal Pharmaceuticals LLC	70121-1711	70121-1711-0270121-1711-09
Dexmedetomidine Hydrochloridedexmedetomidine hydrochloride in sodium chloride	Dexmedetomidine hydrochloride 4 ug/mL	InjectionIntravenous	Amneal Pharmaceuticals LLC	70121-1712	70121-1712-0270121-1712-03

All 39 Dexmedetomidine Hydrochloride NDCs

Other NDCs under ANDA 212571

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

FDA NDC Directory listings under ANDA 212571
Product	Strength	Form · route	Labeler	Product NDC
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 400 ug/100mL	Injection, SolutionIntravenous	Mylan Institutional LLC	67457-925