Prescription drug · ANDA
Dexmedetomidine Hydrochloride NDC 57664-596
Dexmedetomidine hydrochloride 100 ug/mL · Injection, Solution · Intravenous · Sun Pharmaceuticals Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57664-596-50 | 57664059650 | 25 VIAL, SINGLE-DOSE in 1 CARTON (57664-596-50) / 2 mL in 1 VIAL, SINGLE-DOSE (57664-596-40)Marketed from Apr 8, 2015 |
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
- 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 57664-596_1086cd9a-8975-4c42-a120-f8b70c9a7bdbSPL ID 1086cd9a-8975-4c42-a120-f8b70c9a7bdbSPL set ID 4fe788bc-4ad1-4b32-83d3-dcbfcd8429aaRxCUI 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
N457664059650followed by a unit qualifier and the quantityPackage 57664-0596-50. 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 non-intubated patients prior to and/or during surgical and other procedures. (1.2) 1.2 Procedural Sedation Dexmedetomidine hydrochloride injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.
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 | 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 200 ug/2mL | Injection, SolutionIntravenous | ProPharma Distribution | 84549-230 |
| 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 |