Prescription drug · ANDA
Dexmedetomidine Hydrochloride NDC 71872-7031
Dexmedetomidine hydrochloride 100 ug/mL · Injection, Solution · Intravenous · Medical Purchasing Solutions, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71872-7031-1 | 71872703101 | 1 VIAL in 1 BAG (71872-7031-1) / 2 mL in 1 VIALMarketed from Mar 2, 2020 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- 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 71872-7031_fd1604d4-5081-7e98-e053-6394a90af8aaSPL ID fd1604d4-5081-7e98-e053-6394a90af8aaSPL set ID a268e759-9a3e-1d7b-e053-2a95a90a335bRxCUI 309710UNII 1018WH7F9IUPC 0371872703116
- 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
N471872703101followed by a unit qualifier and the quantityPackage 71872-7031-01. 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 hydrochloride injection is a relatively selective alpha 2 -adrenergic agonist indicated for: Sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Administer dexmedetomidine hydrochloride injection by continuous infusion not to exceed 24 hours. ( 1.1 ) Sedation of non-intubated patients prior to and/or during surgical and other procedures. ( 1.2 ) 1.1 Intensive Care Unit Sedation Dexmedetomidine hydrochloride injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Dexmedetomidine hydrochloride injection should be administered by …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205867
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, SolutionIntravenous | Eugia US LLC | 55150-209 |