Dexmedetomidine Hydrochloride NDC 70121-1388

NDC codes

FDA NDC Directory

Product NDC (as listed)70121-1388Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70121-1388Add 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 NDC	11-digit (billing)	Package	Copy
70121-1388-8	70121138808	20 BOTTLE, GLASS in 1 CARTON (70121-1388-8) / 50 mL in 1 BOTTLE, GLASS (70121-1388-1)Marketed from May 20, 2020

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Amneal Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207551
Marketing start: May 20, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)General Anesthesia (Physiologic effect)
Identifiers: Product ID 70121-1388_af193b53-1488-401f-8f06-cc193297c4a8SPL ID af193b53-1488-401f-8f06-cc193297c4a8SPL set ID eb1ba463-ab42-4f49-9ebe-3ad5af108326RxCUI 1718906, 1718909UNII 1018WH7F9IUPC 0370121138914, 0370121138815
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

N470121138808 followed by a unit qualifier and the quantity

Package 70121-1388-08. 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 May 28, 2026.

Indications (excerpt from the label)

Dexmedetomidine hydrochloride 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 dexmedetomidine hydrochloride in 0.9% sodium chloride injection 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) 1.1 Intensive Care Unit Sedation Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Dexmedetomidine hydrochlor…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207551

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

FDA NDC Directory listings under ANDA 207551
Product	Strength	Form · route	Labeler	Product NDC
Dexmedetomidine Hydrochloride	Dexmedetomidine hydrochloride 4 ug/mL	Injection, SolutionIntravenous	Amneal Pharmaceuticals LLC	70121-1389