NDC codes

FDA NDC Directory
Product NDC (as listed)0409-7853Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00409-7853Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0409-7853-240040978532424 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
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.

How CPT relates to drug billing

NDC on a medical claim

N400409785324 followed by a unit qualifier and the quantity

Package 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under NDA 021038

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021038
ProductStrengthForm · routeLabelerProduct NDC
Precedexdexmedetomidine hydrochlorideDexmedetomidine hydrochloride 4 ug/mLInjection, SolutionIntravenousHospira, Inc.0409-4596
Precedexdexmedetomidine hydrochlorideDexmedetomidine hydrochloride 4 ug/mLInjection, SolutionIntravenousHospira, Inc.0409-2815
Precedexdexmedetomidine hydrochlorideDexmedetomidine hydrochloride 4 ug/mLInjection, SolutionIntravenousHospira, Inc.0409-7838
Precedexdexmedetomidine hydrochlorideDexmedetomidine hydrochloride 4 ug/mLInjection, SolutionIntravenousHospira, Inc.0409-1596
Precedexdexmedetomidine hydrochlorideDexmedetomidine hydrochloride 4 ug/mLInjection, SolutionIntravenousHospira, Inc.0409-7875
Precedexdexmedetomidine hydrochlorideDexmedetomidine hydrochloride 100 ug/mLInjection, Solution, ConcentrateIntravenousHospira, Inc.0409-1638
Precedexdexmedetomidine hydrochlorideDexmedetomidine hydrochloride 4 ug/mLInjection, SolutionIntravenousHospira, Inc.0409-1660
Precedexdexmedetomidine hydrochlorideDexmedetomidine hydrochloride 4 ug/mLInjection, SolutionIntravenousHospira, Inc.0409-1434
Precedexdexmedetomidine hydrochlorideDexmedetomidine hydrochloride 4 ug/mLInjection, SolutionIntravenousHospira, Inc.0409-1454
Precedexdexmedetomidine hydrochlorideDexmedetomidine hydrochloride 4 ug/mLInjection, SolutionIntravenousHospira, Inc.0409-1174
Precedexdexmedetomidine hydrochlorideDexmedetomidine hydrochloride 4 ug/mLInjection, SolutionIntravenousHospira, Inc.0409-3301
Precedexdexmedetomidine hydrochlorideDexmedetomidine hydrochloride 100 ug/mLInjection, Solution, ConcentrateIntravenousHenry Schein, Inc.0404-9938
Precedexdexmedetomidine hydrochlorideDexmedetomidine hydrochloride 4 ug/mLInjection, SolutionIntravenousHospira, Inc.0409-0155

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