Prescription drug · ANDA
Dexmedetomidine NDC 66794-233
Dexmedetomidine hydrochloride 200 ug/2mL · Injection, Solution · Intravenous · Piramal Critical Care Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66794-233-42 | 6679402334266794023342 | 25 VIAL, GLASS in 1 CARTON (66794-233-42) / 2 mL in 1 VIAL, GLASS (66794-233-02)Marketed from May 1, 2021 |
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 — 200 ug/2mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Piramal Critical Care IncNDC labeler code 66794
- 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 66794-233_552143bf-29d0-9fdc-e063-6394a90a7b7cSPL ID 552143bf-29d0-9fdc-e063-6394a90a7b7cSPL set ID c116d83f-35da-19ca-e053-2a95a90a017dRxCUI 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
N466794023342followed by a unit qualifier and the quantityPackage 66794-0233-42. 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 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 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 treatment…
Excerpt only. Read the full label for complete information.
About NDC 66794-233
- What is NDC 66794-233?
- 66794-233 is the product NDC for Dexmedetomidine, Dexmedetomidine hydrochloride 200 ug/2mL injection, solution, listed with the FDA by Piramal Critical Care Inc. 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?
- Piramal Critical Care Inc, NDC labeler code 66794. 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 | 66794-230 | 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 |
| Dexmedetomidine | Dexmedetomidine hydrochloride 100 ug/mL | Injection, Solution, ConcentrateIntravenous | WG Critical Care, LLC | 44567-601 | 44567-0601-04 |
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 | Dexmedetomidine hydrochloride 200 ug/2mL | Injection, SolutionIntravenous | Piramal Critical Care Inc | 66794-230 |
| 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 |
| Dexmedetomidine | Dexmedetomidine hydrochloride 200 ug/2mL | Injection, SolutionIntravenous | ProPharma Distribution | 84549-230 |
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 100 ug/mL | Injection, SolutionIntravenous | Sun Pharmaceuticals Industries, Inc. | 57664-596 |
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 100 ug/mL | Injection, SolutionIntravenous | Medical Purchasing Solutions, LLC | 71872-7122 |