Prescription drug · NDA
Precedex (Dexmedetomidine hydrochloride) NDC 0409-7853
Dexmedetomidine hydrochloride 4 ug/mL · Injection, Solution · Intravenous · Hospira, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0409-7853-24 | 0040978532400409785324 | 24 POUCH in 1 CASE (0409-7853-24) / 1 BAG in 1 POUCH / 100 mL in 1 BAG (0409-7853-01)Marketed from Mar 24, 2025 |
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)
- Precedex
- Generic name (nonproprietary)
- dexmedetomidine hydrochloride
- Active ingredients
- Dexmedetomidine hydrochloride — 4 ug/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Hospira, Inc.NDC labeler code 0409
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021038
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)General Anesthesia (Physiologic effect)
- Identifiers
- Product ID 0409-7853_3c5274fd-6597-4b88-babc-92e4e16c6329SPL ID 3c5274fd-6597-4b88-babc-92e4e16c6329SPL set ID 548a88c0-afda-427e-75ac-5af0cfa2224cRxCUI 284397, 309710, 1718900, 1718902, 1718906, 1718907, 1718909, 1718910, 2396891, 2396892UNII 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
N400409785324followed by a unit qualifier and the quantityPackage 00409-7853-24. 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)
PRECEDEX 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 PRECEDEX 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 PRECEDEX is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. PRECEDEX shoul…
Excerpt only. Read the full label for complete information.
About NDC 0409-7853
- What is NDC 0409-7853?
- 0409-7853 is the product NDC for Precedex (dexmedetomidine hydrochloride), Dexmedetomidine hydrochloride 4 ug/mL injection, solution, listed with the FDA by Hospira, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Precedex (Dexmedetomidine hydrochloride).
- What is the active ingredient?
- Dexmedetomidine hydrochloride.
- Who is the labeler?
- Hospira, Inc., NDC labeler code 0409. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Precedex?
- 13 other product NDCs are listed under this name. See all Precedex NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Precedex products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Precedexdexmedetomidine hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-7838 | 00409-7838-24 |
| Precedexdexmedetomidine hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-7875 | 00409-7875-12 |
| Precedexdexmedetomidine hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-1596 | 00409-1596-10 |
| Precedexdexmedetomidine hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-2815 | 00409-2815-01 |
| Precedexdexmedetomidine hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-0155 | 00409-0155-02 |
| Precedexdexmedetomidine hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-4596 | 00409-4596-20 |
| Precedexdexmedetomidine hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-1174 | 00409-1174-10 |
| Precedexdexmedetomidine hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-1454 | 00409-1454-20 |
| Precedexdexmedetomidine hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-3301 | 00409-3301-10 |
| Precedexdexmedetomidine hydrochloride | Dexmedetomidine hydrochloride 100 ug/mL | Injection, Solution, ConcentrateIntravenous | Henry Schein, Inc. | 0404-9938 | 00404-9938-02 |
Other NDCs under NDA 021038
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 |
|---|---|---|---|---|
| Precedexdexmedetomidine hydrochloride | Dexmedetomidine hydrochloride 100 ug/mL | Injection, Solution, ConcentrateIntravenous | Henry Schein, Inc. | 0404-9938 |
| Precedexdexmedetomidine hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-0155 |
| Precedexdexmedetomidine hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-1174 |
| Precedexdexmedetomidine hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-1434 |
| Precedexdexmedetomidine hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-1454 |
| Precedexdexmedetomidine hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-1596 |
| Precedexdexmedetomidine hydrochloride | Dexmedetomidine hydrochloride 100 ug/mL | Injection, Solution, ConcentrateIntravenous | Hospira, Inc. | 0409-1638 |
| Precedexdexmedetomidine hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-1660 |
| Precedexdexmedetomidine hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-2815 |
| Precedexdexmedetomidine hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-3301 |
| Precedexdexmedetomidine hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-4596 |
| Precedexdexmedetomidine hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-7838 |
| Precedexdexmedetomidine hydrochloride | Dexmedetomidine hydrochloride 4 ug/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-7875 |