What is NDC 63323-421?

63323-421 is the product NDC for Dexmedetomidine Hydrochloride, Dexmedetomidine hydrochloride 100 ug/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Fresenius Kabi USA, LLC, NDC labeler code 63323. 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 63323-421

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-421Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0421Add 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
63323-421-02	6332304210263323042102	25 VIAL in 1 TRAY (63323-421-02) / 2 mL in 1 VIAL (63323-421-01)Marketed from Sep 18, 2015

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 — 100 ug/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Fresenius Kabi USA, LLCNDC labeler code 63323
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201072
Marketing start: Sep 18, 2015
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)General Anesthesia (Physiologic effect)
Identifiers: Product ID 63323-421_56e0af34-aeb5-4b37-8c61-2e90b2c8ca6cSPL ID 56e0af34-aeb5-4b37-8c61-2e90b2c8ca6cSPL set ID c1b8eb58-596b-481d-beb6-ba9d2237abf4RxCUI 309710UNII 1018WH7F9IUPC 0363323421014
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

N463323042102 followed by a unit qualifier and the quantity

Package 63323-0421-02. 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 Sep 22, 2025.

Indications (excerpt from the label)

Dexmedetomidine hydrochloride 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 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 ) 1.1 Intensive Care Unit Sedation Dexmedetomidine Injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Dexmedetomidine Injection should be administered by continuous infusion not to exceed 24 h…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63323-421

What is NDC 63323-421?: 63323-421 is the product NDC for Dexmedetomidine Hydrochloride, Dexmedetomidine hydrochloride 100 ug/mL injection, solution, listed with the FDA by Fresenius Kabi USA, 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?: Fresenius Kabi USA, LLC, NDC labeler code 63323. 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 201072

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

FDA NDC Directory listings under ANDA 201072
Product	Strength	Form · route	Labeler	Product NDC
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 100 ug/mL	Injection, SolutionIntravenous	Fresenius Kabi USA, LLC	65219-642