NDC codes

FDA NDC Directory
Product NDC (as listed)55150-209Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55150-0209Add 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 NDC11-digit (billing)PackageCopy
55150-209-02551500209025515002090225 VIAL in 1 CARTON (55150-209-02) / 2 mL in 1 VIALMarketed from Mar 17, 2016

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
Eugia US LLCNDC labeler code 55150
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205867
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha2-Agonists (Mechanism)General Anesthesia (Physiologic effect)
Identifiers
Product ID 55150-209_a1eab62d-fcef-4b83-9266-3c5f7a05927bSPL ID a1eab62d-fcef-4b83-9266-3c5f7a05927bSPL set ID 8c162541-986b-4b30-866c-b2631ba2c975RxCUI 309710, 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

N455150020902 followed by a unit qualifier and the quantity

Package 55150-0209-02. 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 .

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 treatment…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55150-209

What is NDC 55150-209?
55150-209 is the product NDC for Dexmedetomidine, Dexmedetomidine hydrochloride 100 ug/mL injection, solution, listed with the FDA by Eugia US LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dexmedetomidine.
What is the active ingredient?
Dexmedetomidine hydrochloride.
Who is the labeler?
Eugia US LLC, NDC labeler code 55150. 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?
12 other product NDCs are listed under this name. See all Dexmedetomidine 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DexmedetomidineDexmedetomidine hydrochloride 100 ug/mLInjection, Solution, ConcentrateIntravenousAvenacy Inc.83634-60083634-0600-02
DexmedetomidineDexmedetomidine hydrochloride 100 ug/mLInjection, SolutionIntravenousGland Pharma Limited68083-52768083-0527-25
DexmedetomidineDexmedetomidine hydrochloride 200 ug/2mLInjection, SolutionIntravenousPiramal Critical Care Inc66794-23366794-0233-42
DexmedetomidineDexmedetomidine hydrochloride 200 ug/2mLInjection, SolutionIntravenousPiramal Critical Care Inc66794-23066794-0230-42
DexmedetomidineDexmedetomidine hydrochloride 200 ug/2mLInjection, SolutionIntravenousMedical Purchasing Solutions, LLC71872-732371872-7323-01
DexmedetomidineDexmedetomidine hydrochloride 200 ug/2mLInjection, SolutionIntravenousProPharma Distribution84549-23084549-0230-42
DexmedetomidineDexmedetomidine hydrochloride 100 ug/mLInjection, SolutionIntravenousMeitheal Pharmaceuticals Inc.71288-50571288-0505-03
DexmedetomidineDexmedetomidine hydrochloride 100 ug/mLInjection, SolutionIntravenousProPharma Distribution84549-50584549-0505-03
DexmedetomidineDexmedetomidine hydrochloride 100 ug/mLInjection, SolutionIntravenousAccord Healthcare Inc.16729-23916729-0239-93
DexmedetomidineDexmedetomidine hydrochloride 100 ug/mLInjection, Solution, ConcentrateIntravenousWG Critical Care, LLC44567-60044567-0600-04

All 13 Dexmedetomidine NDCs

Other NDCs under ANDA 205867

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

FDA NDC Directory listings under ANDA 205867
ProductStrengthForm · routeLabelerProduct NDC
Dexmedetomidine HydrochlorideDexmedetomidine hydrochloride 100 ug/mLInjection, SolutionIntravenousMedical Purchasing Solutions, LLC71872-7031

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