What is NDC 71288-505?

71288-505 is the product NDC for Dexmedetomidine, Dexmedetomidine hydrochloride 100 ug/mL injection, solution, listed with the FDA by Meitheal Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Meitheal Pharmaceuticals Inc., NDC labeler code 71288. 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?

12 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Dexmedetomidine NDC 71288-505 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71288-505Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71288-0505Add 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
71288-505-03	7128805050371288050503	25 VIAL, SINGLE-DOSE in 1 CARTON (71288-505-03) / 2 mL in 1 VIAL, SINGLE-DOSE (71288-505-02)Marketed from Jan 18, 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
Generic name (nonproprietary): dexmedetomidine
Active ingredients: Dexmedetomidine hydrochloride — 100 ug/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Meitheal Pharmaceuticals Inc.NDC labeler code 71288
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204843
Marketing start: Jan 18, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)General Anesthesia (Physiologic effect)
Identifiers: Product ID 71288-505_aa312d38-51c9-4615-a1ad-7dd639394b0fSPL ID aa312d38-51c9-4615-a1ad-7dd639394b0fSPL set ID 8fa36783-b94d-4084-8c41-40ee64192074RxCUI 309710UNII 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

N471288050503 followed by a unit qualifier and the quantity

Package 71288-0505-03. 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 Aug 3, 2026.

Indications (excerpt from the label)

Dexmedetomidine Injection 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 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 Injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Dexmedetomidine Injection should be administered by continuous infusion not to exceed 24 hours. Dexmed…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71288-505

What is NDC 71288-505?: 71288-505 is the product NDC for Dexmedetomidine, Dexmedetomidine hydrochloride 100 ug/mL injection, solution, listed with the FDA by Meitheal Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Dexmedetomidine.
What is the active ingredient?: Dexmedetomidine hydrochloride.
Who is the labeler?: Meitheal Pharmaceuticals Inc., NDC labeler code 71288. 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?: 12 other product NDCs are listed under this name. See all Dexmedetomidine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Dexmedetomidine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Dexmedetomidine	Dexmedetomidine hydrochloride 100 ug/mL	Injection, Solution, ConcentrateIntravenous	Avenacy Inc.	83634-600	83634-0600-02
Dexmedetomidine	Dexmedetomidine hydrochloride 100 ug/mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-527	68083-0527-25
Dexmedetomidine	Dexmedetomidine hydrochloride 200 ug/2mL	Injection, SolutionIntravenous	Piramal Critical Care Inc	66794-233	66794-0233-42
Dexmedetomidine	Dexmedetomidine hydrochloride 200 ug/2mL	Injection, SolutionIntravenous	Piramal Critical Care Inc	66794-230	66794-0230-42
Dexmedetomidine	Dexmedetomidine hydrochloride 200 ug/2mL	Injection, SolutionIntravenous	Medical Purchasing Solutions, LLC	71872-7323	71872-7323-01
Dexmedetomidine	Dexmedetomidine hydrochloride 200 ug/2mL	Injection, SolutionIntravenous	ProPharma Distribution	84549-230	84549-0230-42
Dexmedetomidine	Dexmedetomidine hydrochloride 100 ug/mL	Injection, SolutionIntravenous	ProPharma Distribution	84549-505	84549-0505-03
Dexmedetomidine	Dexmedetomidine hydrochloride 100 ug/mL	Injection, SolutionIntravenous	Accord Healthcare Inc.	16729-239	16729-0239-93
Dexmedetomidine	Dexmedetomidine hydrochloride 100 ug/mL	Injection, Solution, ConcentrateIntravenous	WG Critical Care, LLC	44567-600	44567-0600-04
Dexmedetomidine	Dexmedetomidine hydrochloride 100 ug/mL	Injection, Solution, ConcentrateIntravenous	WG Critical Care, LLC	44567-601	44567-0601-04

All 13 Dexmedetomidine NDCs

Other NDCs under ANDA 204843

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

FDA NDC Directory listings under ANDA 204843
Product	Strength	Form · route	Labeler	Product NDC
Dexmedetomidine	Dexmedetomidine hydrochloride 100 ug/mL	Injection, SolutionIntravenous	ProPharma Distribution	84549-505