Prescription drug · ANDA
Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride NDC 0781-3495
Dexmedetomidine hydrochloride 4 ug/mL · Injection · Intravenous · Sandoz Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-3495-95 | 0078134959500781349595 | 10 BOTTLE in 1 CARTON (0781-3495-95) / 100 mL in 1 BOTTLEMarketed from Jun 12, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 0.9% Sodium Chloride
- Generic name (nonproprietary)
- dexmedetomidine hydrochloride in 0.9% sodium chloride
- Active ingredients
- Dexmedetomidine hydrochloride — 4 ug/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Sandoz Inc.NDC labeler code 0781
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209065
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)General Anesthesia (Physiologic effect)
- Identifiers
- Product ID 0781-3495_5a0d944c-af38-a3fd-e063-6294a90aed62SPL ID 5a0d944c-af38-a3fd-e063-6294a90aed62SPL set ID 809e8f77-390f-4cc8-8c8a-4f67a249c9dfRxCUI 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
N400781349595followed by a unit qualifier and the quantityPackage 00781-3495-95. 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 ) Sedation of non-intubated pediatric patients aged 1 month to less than 18 years prior to and during non-invasive procedures. ( 1.2 ) 1.1 Intensive Care Unit Sedation Dexmedetomidine hydrochloride in 0.9% sodium chloride inje…
Excerpt only. Read the full label for complete information.
About NDC 0781-3495
- What is NDC 0781-3495?
- 0781-3495 is the product NDC for Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride, Dexmedetomidine hydrochloride 4 ug/mL injection, listed with the FDA by Sandoz Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride.
- What is the active ingredient?
- Dexmedetomidine hydrochloride.
- Who is the labeler?
- Sandoz Inc., NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride?
- 6 other product NDCs are listed under this name. See all Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dexmedetomidine Hydrochloride in 0.9% Sodium Chloridedexmedetomidine hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-615 | 25021-0615-5025021-0615-51 |
| Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | Sandoz Inc. | 0781-3493 | 00781-3493-95 |
| Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | Sandoz Inc. | 0781-3494 | 00781-3494-95 |
| Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | ProPharma Distribution | 84549-493 | 84549-0493-95 |
| Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride | Dexmedetomidine hydrochloride 200 ug/50mL | InjectionIntravenous | Baxter Healthcare Company | 43066-555 | 43066-0555-24 |
| Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride | Dexmedetomidine hydrochloride 400 ug/100mL | InjectionIntravenous | Baxter Healthcare Company | 43066-557 | 43066-0557-12 |
Other NDCs under ANDA 209065
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, Solution, ConcentrateIntravenous | Avenacy Inc. | 83634-600 |
| Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | Sandoz Inc. | 0781-3493 |
| Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | Sandoz Inc. | 0781-3494 |
| Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | ProPharma Distribution | 84549-493 |