Prescription drug · NDA
Dexmedetomidine in Dextrose (dexmedetomidine) NDC 44567-602
Dexmedetomidine hydrochloride 4 ug/mL · Injection · Intravenous · WG Critical Care, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 44567-602-24 | 44567060224 | 24 BAG in 1 CARTON (44567-602-24) / 50 mL in 1 BAGMarketed from Oct 18, 2018 |
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 in Dextrose
- Generic name (nonproprietary)
- dexmedetomidine
- Active ingredients
- Dexmedetomidine hydrochloride — 4 ug/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- WG Critical Care, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 206628
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)General Anesthesia (Physiologic effect)
- Identifiers
- Product ID 44567-602_42a0bb50-be84-4c46-abfd-fd44c6f10087SPL ID 42a0bb50-be84-4c46-abfd-fd44c6f10087SPL set ID 0d2710f2-ee47-4114-ab5c-8dca74cdcb8dRxCUI 1718906, 1718909, 1788947UNII 1018WH7F9IUPC 0344567603244
- 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.
- NDC on a medical claim
N444567060224followed by a unit qualifier and the quantityPackage 44567-0602-24. 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 and Dexmedetomidine in 5% Dextrose 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 and Dexmedetomidine in 5% Dextrose 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) 1.1 Intensive Care Unit Sedation Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatmen…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 206628
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Dexmedetomidine | Dexmedetomidine hydrochloride 100 ug/mL | Injection, Solution, ConcentrateIntravenous | WG Critical Care, LLC | 44567-600 |
| Dexmedetomidine | Dexmedetomidine hydrochloride 100 ug/mL | Injection, Solution, ConcentrateIntravenous | WG Critical Care, LLC | 44567-601 |
| Dexmedetomidine in Dextrosedexmedetomidine | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | WG Critical Care, LLC | 44567-603 |