Prescription drug · ANDA
Dexmedetomidine Hydrochloride NDC 52536-126
Dexmedetomidine hydrochloride 4 ug/mL · Injection · Intravenous · Wilshire Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52536-126-08 | 52536012608 | 8 BOTTLE in 1 CARTON (52536-126-08) / 100 mL in 1 BOTTLE (52536-126-01)Marketed from Jan 30, 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212791
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)General Anesthesia (Physiologic effect)
- Identifiers
- Product ID 52536-126_f550d2ba-49ac-4a3b-95db-692b468af479SPL ID f550d2ba-49ac-4a3b-95db-692b468af479SPL set ID f550d2ba-49ac-4a3b-95db-692b468af479RxCUI 1718906, 1718909UNII 1018WH7F9IUPC 0352536125017, 0352536126014
- 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
N452536012608followed by a unit qualifier and the quantityPackage 52536-0126-08. 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 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 hydrochloride 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 hydrochloride in 0.9% sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensiv…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212791
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 | InjectionIntravenous | CIVICA, INC. | 72572-128 |
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | CIVICA, INC. | 72572-127 |
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | Wilshire Pharmaceuticals, Inc. | 52536-125 |