Prescription drug · ANDA
Dexmedetomidine Hydrochloride NDC 25021-617
Dexmedetomidine hydrochloride 4 ug/mL · Injection · Intravenous · Sagent Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25021-617-82 | 25021061782 | 20 BAG in 1 CARTON (25021-617-82) / 100 mL in 1 BAGMarketed from Jul 15, 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 Hydrochloride
- Generic name (nonproprietary)
- dexmedetomidine hydrochloride
- Active ingredients
- Dexmedetomidine hydrochloride — 4 ug/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Sagent Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209307
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)General Anesthesia (Physiologic effect)
- Identifiers
- Product ID 25021-617_56ca6ba0-864c-4360-8791-0bd8399b2a2bSPL ID 56ca6ba0-864c-4360-8791-0bd8399b2a2bSPL set ID 65885aef-faaf-4dec-a180-9a657f738bbcRxCUI 1718909UNII 1018WH7F9IUPC 0325021617823
- 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
N425021061782followed by a unit qualifier and the quantityPackage 25021-0617-82. 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.
Other NDCs under ANDA 209307
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 4 ug/mL | Injection, SolutionIntravenous | Dr.Reddy's Laboratories Inc | 43598-976 |
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | Gland Pharma Limited | 68083-238 |
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | Gland Pharma Limited | 68083-239 |
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | Injection, SolutionIntravenous | Dr.Reddy's Laboratories Inc | 43598-975 |
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | Piramal Critical Care Inc | 66794-234 |
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | Piramal Critical Care Inc | 66794-235 |
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | Gland Pharma Limited | 68083-657 |