Prescription drug · NDA
Dexmedetomidine NDC 44567-600
Dexmedetomidine hydrochloride 100 ug/mL · Injection, Solution, Concentrate · Intravenous · WG Critical Care, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 44567-600-04 | 4456706000444567060004 | 4 VIAL in 1 CARTON (44567-600-04) / 4 mL in 1 VIALMarketed from Jan 26, 2017 |
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
- WG Critical Care, LLCNDC labeler code 44567
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 206628
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)General Anesthesia (Physiologic effect)
- Identifiers
- Product ID 44567-600_ee503974-3f79-46d7-845f-2d15444dc0b8SPL ID ee503974-3f79-46d7-845f-2d15444dc0b8
- 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
N444567060004followed by a unit qualifier and the quantityPackage 44567-0600-04. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 44567-600
- What is NDC 44567-600?
- 44567-600 is the product NDC for Dexmedetomidine, Dexmedetomidine hydrochloride 100 ug/mL injection, solution, concentrate, listed with the FDA by WG Critical Care, 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?
- WG Critical Care, LLC, NDC labeler code 44567. 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 | 44567-601 | 44567-0601-04 |
Other NDCs under NDA 206628
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 | WG Critical Care, LLC | 44567-601 |
| Dexmedetomidine in Dextrosedexmedetomidine | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | WG Critical Care, LLC | 44567-602 |
| Dexmedetomidine in Dextrosedexmedetomidine | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | WG Critical Care, LLC | 44567-603 |