Prescription drug · ANDA
Dexmedetomidine NDC 84549-230
Dexmedetomidine hydrochloride 200 ug/2mL · Injection, Solution · Intravenous · ProPharma Distribution
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84549-230-42 | 84549023042 | 2 mL in 1 VIAL, GLASS (84549-230-42)Marketed from Oct 10, 2025 |
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 — 200 ug/2mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- ProPharma Distribution
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202126
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)General Anesthesia (Physiologic effect)
- Identifiers
- Product ID 84549-230_463e2d32-6340-7873-e063-6294a90a96f1SPL ID 463e2d32-6340-7873-e063-6294a90a96f1SPL set ID 42cbeadf-fea3-d2ae-e063-6394a90ad549RxCUI 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.
- NDC on a medical claim
N484549023042followed by a unit qualifier and the quantityPackage 84549-0230-42. 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)
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 hours. Dexmedetomidine injection has been continuously infused in mechanically ventilated adult patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue dexmedetomidine injection prior to extubation. 1.2 Procedural Sedation Dexmedetomidine injection is indicated for sedation of non-intubated adult patients prior to and/or during surgical and other procedures. Ped…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202126
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 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 100 ug/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-527 |
| Dexmedetomidine | Dexmedetomidine hydrochloride 200 ug/2mL | Injection, SolutionIntravenous | Medical Purchasing Solutions, LLC | 71872-7323 |