Prescription drug · ANDA
Dexmedetomidine Hydrochloride NDC 65219-642
Dexmedetomidine hydrochloride 100 ug/mL · Injection, Solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65219-642-02 | 65219064202 | 25 VIAL in 1 TRAY (65219-642-02) / 2 mL in 1 VIAL (65219-642-01)Marketed from Dec 13, 2024 |
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, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201072
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)General Anesthesia (Physiologic effect)
- Identifiers
- Product ID 65219-642_1896a96e-25f8-494e-9a96-6463b52fb102SPL ID 1896a96e-25f8-494e-9a96-6463b52fb102SPL set ID 1896a96e-25f8-494e-9a96-6463b52fb102RxCUI 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
N465219064202followed by a unit qualifier and the quantityPackage 65219-0642-02. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.