Prescription drug · ANDA
Dexmedetomidine Hydrochloride NDC 0143-9526
Dexmedetomidine hydrochloride 4 ug/mL · Injection, Solution · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9526-10 | 0014395261000143952610 | 10 POUCH in 1 CASE (0143-9526-10) / 1 BAG in 1 POUCH / 50 mL in 1 BAGMarketed from Jan 30, 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
- Generic name (nonproprietary)
- dexmedetomidine hydrochloride
- Active ingredients
- Dexmedetomidine hydrochloride — 4 ug/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206407
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)General Anesthesia (Physiologic effect)
- Identifiers
- Product ID 0143-9526_8a63d5e8-de78-4117-8371-25880eb3eb00SPL ID 8a63d5e8-de78-4117-8371-25880eb3eb00
- 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
N400143952610followed by a unit qualifier and the quantityPackage 00143-9526-10. 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 0143-9526
- What is NDC 0143-9526?
- 0143-9526 is the product NDC for Dexmedetomidine Hydrochloride, Dexmedetomidine hydrochloride 4 ug/mL injection, solution, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dexmedetomidine Hydrochloride.
- What is the active ingredient?
- Dexmedetomidine hydrochloride.
- Who is the labeler?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. 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?
- 38 other product NDCs are listed under this name. See all Dexmedetomidine Hydrochloride 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 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 | Dexmedetomidine hydrochloride 100 ug/mL | Injection, Solution, ConcentrateIntravenous | Baxter Healthcare Corporation | 36000-262 | 36000-0262-0536000-0262-1036000-0262-25 |
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9198 | 00143-9198-10 |
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | Sagent Pharmaceuticals | 25021-617 | 25021-0617-82 |
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | Wilshire Pharmaceuticals, Inc. | 52536-125 | 52536-0125-10 |
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | Wilshire Pharmaceuticals, Inc. | 52536-126 | 52536-0126-08 |
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | Gland Pharma Limited | 68083-657 | 68083-0657-10 |
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 100 ug/mL | Injection, SolutionIntravenous | Somerset Therapeutics, LLC | 70069-758 | 70069-0758-04 |
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 100 ug/mL | Injection, SolutionIntravenous | Somerset Therapeutics, LLC | 70069-759 | 70069-0759-04 |
| Dexmedetomidine Hydrochloridedexmedetomidine hydrochloride in sodium chloride | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | Amneal Pharmaceuticals LLC | 70121-1711 | 70121-1711-0270121-1711-09 |
| Dexmedetomidine Hydrochloridedexmedetomidine hydrochloride in sodium chloride | Dexmedetomidine hydrochloride 4 ug/mL | InjectionIntravenous | Amneal Pharmaceuticals LLC | 70121-1712 | 70121-1712-0270121-1712-03 |
Other NDCs under ANDA 206407
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 4 ug/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9198 |
| Dexmedetomidine Hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9525 |