Prescription drug · ANDA
Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride NDC 43066-557
Dexmedetomidine hydrochloride 400 ug/100mL · Injection · Intravenous · Baxter Healthcare Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43066-557-12 | 4306605571243066055712 | 12 BAG in 1 CARTON (43066-557-12) / 100 mL in 1 BAGMarketed from Aug 27, 2019 |
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 In 0.9% Sodium Chloride
- Generic name (nonproprietary)
- dexmedetomidine hydrochloride in 0.9% sodium chloride
- Active ingredients
- Dexmedetomidine hydrochloride — 400 ug/100mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Baxter Healthcare CompanyNDC labeler code 43066
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208532
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)General Anesthesia (Physiologic effect)
- Identifiers
- Product ID 43066-557_5ae6fcf6-cd01-4b89-af44-962f5452fe72SPL ID 5ae6fcf6-cd01-4b89-af44-962f5452fe72
- 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
N443066055712followed by a unit qualifier and the quantityPackage 43066-0557-12. 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 43066-557
- What is NDC 43066-557?
- 43066-557 is the product NDC for Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride, Dexmedetomidine hydrochloride 400 ug/100mL injection, listed with the FDA by Baxter Healthcare Company. 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?
- Baxter Healthcare Company, NDC labeler code 43066. 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 | Sandoz Inc. | 0781-3495 | 00781-3495-95 |
| 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 |
Other NDCs under ANDA 208532
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 200 ug/50mL | InjectionIntravenous | Baxter Healthcare Company | 43066-561 |
| Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride | Dexmedetomidine hydrochloride 200 ug/50mL | InjectionIntravenous | Baxter Healthcare Company | 43066-555 |
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 400 ug/100mL | InjectionIntravenous | Baxter Healthcare Company | 43066-565 |
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 200 ug/50mL | InjectionIntravenous | Baxter Healthcare Company | 0338-9555 |
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 400 ug/100mL | InjectionIntravenous | Baxter Healthcare Company | 0338-9557 |