Prescription drug · ANDA
Dexmedetomidine Hydrochloride in Sodium Chloride NDC 68094-247
dexmedetomidine hydrochloride · Dexmedetomidine hydrochloride 4 ug/mL · Injection, Solution · Intravenous · Precision Dose, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68094-247-10 | 68094024710 | 10 BOTTLE in 1 CARTON (68094-247-10) / 100 mL in 1 BOTTLE (68094-247-01)Marketed from Nov 23, 2020 |
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 in Sodium Chloride
- Generic name (nonproprietary)
- dexmedetomidine hydrochloride
- Active ingredients
- Dexmedetomidine hydrochloride — 4 ug/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Precision Dose, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212857
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)General Anesthesia (Physiologic effect)
- Identifiers
- Product ID 68094-247_721350a6-f9ae-4c06-b8b5-41169d7cd43eSPL ID 721350a6-f9ae-4c06-b8b5-41169d7cd43eSPL set ID e9d5c989-ebf6-4377-9c6e-7aef848a03a1RxCUI 1718900, 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.
- NDC on a medical claim
N468094024710followed by a unit qualifier and the quantityPackage 68094-0247-10. 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. INDICATIONS AND USAGE Dexmedetomidine hydrochloride (HCl) in 0.9% sodium chloride 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 HCl in 0.9% sodium chloride 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 HCl in 0.9% sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212857
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 in Sodium Chloridedexmedetomidine hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | Injection, SolutionIntravenous | Precision Dose, Inc. | 68094-047 |
| Dexmedetomidine Hydrochloride in Sodium Chloridedexmedetomidine hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | Injection, SolutionIntravenous | Precision Dose, Inc. | 68094-147 |