What is NDC 71558-590?

71558-590 is the product NDC for Arikayce (amikacin), Amikacin 590 mg/8.4mL suspension, listed with the FDA by Insmed Incorporated. It has 1 package NDC, shown above in 10- and 11-digit form.

Insmed Incorporated, NDC labeler code 71558. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Arikayce?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Arikayce NDC 71558-590 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71558-590Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71558-0590Add 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
71558-590-28	71558059028	28 VIAL in 1 CARTON (71558-590-28) / 8.4 mL in 1 VIALMarketed from Oct 12, 2018

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): Arikayce
Generic name (nonproprietary): amikacin
Active ingredients: Amikacin — 590 mg/8.4mL
Dosage form: Suspension
Route: Respiratory (Inhalation)
Labeler: Insmed IncorporatedNDC labeler code 71558
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 207356
Marketing start: Oct 12, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Aminoglycosides (Chemical structure)
Identifiers: Product ID 71558-590_8b162ccf-7672-4cd4-9448-7d104971418fSPL ID 8b162ccf-7672-4cd4-9448-7d104971418fSPL set ID 499ab990-2b21-474f-aaba-d86388965f40RxCUI 2059184, 2059189UNII 84319SGC3C
Pharmacologic class: Aminoglycoside Antibacterial

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.

NDC on a medical claim

N471558059028 followed by a unit qualifier and the quantity

Package 71558-0590-28. 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 4, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

LIMITED POPULATION: ARIKAYCE ® is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options . This drug is indicated for use in a limited and specific population of patients. This indication is approved under accelerated approval based on achi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71558-590

What is NDC 71558-590?: 71558-590 is the product NDC for Arikayce (amikacin), Amikacin 590 mg/8.4mL suspension, listed with the FDA by Insmed Incorporated. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Arikayce (Amikacin).
What is the active ingredient?: Amikacin.
Who is the labeler?: Insmed Incorporated, NDC labeler code 71558. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Arikayce?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Arikayce (Amikacin) NDC 71558-590