Prescription drug · ANDA
Dexmedetomidine NDC 67457-251
Dexmedetomidine hydrochloride 100 ug/mL · Injection, Solution, Concentrate · Intravenous · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67457-251-02 | 6745702510267457025102 | 25 VIAL, GLASS in 1 CARTON (67457-251-02) / 2 mL in 1 VIAL, GLASS (67457-251-00)Marketed from Aug 18, 2014 |
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
- Generic name (nonproprietary)
- dexmedetomidine
- Active ingredients
- Dexmedetomidine hydrochloride — 100 ug/mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- Mylan Institutional LLCNDC labeler code 67457
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202881
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)General Anesthesia (Physiologic effect)
- Identifiers
- Product ID 67457-251_afa561b9-9d6c-47b3-87e6-8d049597a0edSPL ID afa561b9-9d6c-47b3-87e6-8d049597a0edSPL set ID ebdfe2e8-30ca-4f18-935a-41bcbbce4937RxCUI 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
N467457025102followed by a unit qualifier and the quantityPackage 67457-0251-02. 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 injection is an 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 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 injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during tr…
Excerpt only. Read the full label for complete information.
About NDC 67457-251
- What is NDC 67457-251?
- 67457-251 is the product NDC for Dexmedetomidine, Dexmedetomidine hydrochloride 100 ug/mL injection, solution, concentrate, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dexmedetomidine.
- What is the active ingredient?
- Dexmedetomidine hydrochloride.
- Who is the labeler?
- Mylan Institutional LLC, NDC labeler code 67457. 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?
- 12 other product NDCs are listed under this name. See all Dexmedetomidine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dexmedetomidine 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 | Dexmedetomidine hydrochloride 100 ug/mL | Injection, Solution, ConcentrateIntravenous | Avenacy Inc. | 83634-600 | 83634-0600-02 |
| Dexmedetomidine | Dexmedetomidine hydrochloride 100 ug/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-527 | 68083-0527-25 |
| Dexmedetomidine | Dexmedetomidine hydrochloride 200 ug/2mL | Injection, SolutionIntravenous | Piramal Critical Care Inc | 66794-233 | 66794-0233-42 |
| Dexmedetomidine | Dexmedetomidine hydrochloride 200 ug/2mL | Injection, SolutionIntravenous | Piramal Critical Care Inc | 66794-230 | 66794-0230-42 |
| Dexmedetomidine | Dexmedetomidine hydrochloride 200 ug/2mL | Injection, SolutionIntravenous | Medical Purchasing Solutions, LLC | 71872-7323 | 71872-7323-01 |
| Dexmedetomidine | Dexmedetomidine hydrochloride 200 ug/2mL | Injection, SolutionIntravenous | ProPharma Distribution | 84549-230 | 84549-0230-42 |
| Dexmedetomidine | Dexmedetomidine hydrochloride 100 ug/mL | Injection, SolutionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-505 | 71288-0505-03 |
| Dexmedetomidine | Dexmedetomidine hydrochloride 100 ug/mL | Injection, SolutionIntravenous | ProPharma Distribution | 84549-505 | 84549-0505-03 |
| Dexmedetomidine | Dexmedetomidine hydrochloride 100 ug/mL | Injection, SolutionIntravenous | Accord Healthcare Inc. | 16729-239 | 16729-0239-93 |
| Dexmedetomidine | Dexmedetomidine hydrochloride 100 ug/mL | Injection, Solution, ConcentrateIntravenous | WG Critical Care, LLC | 44567-600 | 44567-0600-04 |