What is NDC 10122-901?

10122-901 is the product NDC for Zyflo (zileuton), Zileuton 600 mg/1 tablet, listed with the FDA by Chiesi USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Chiesi USA, Inc., NDC labeler code 10122. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Zyflo?

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.

Zyflo NDC 10122-901 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)10122-901Labeler and product segments. Claims need a package NDC.

Product NDC at billing width10122-0901Add 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
10122-901-12	1012209011210122090112	120 TABLET in 1 BOTTLE (10122-901-12)Marketed from Dec 6, 1996

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): Zyflo
Generic name (nonproprietary): zileuton
Active ingredients: Zileuton — 600 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Chiesi USA, Inc.NDC labeler code 10122
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020471
Marketing start: Dec 6, 1996
Marketing end: Nov 30, 2027
Other FDA classes: 5-Lipoxygenase Inhibitors (Mechanism)Decreased Leukotriene Production (Physiologic effect)
Identifiers: Product ID 10122-901_d49e40c7-0635-4220-8b0a-c5068116ee17SPL ID d49e40c7-0635-4220-8b0a-c5068116ee17SPL set ID aee65202-fddb-497f-9f11-17cc727cb157RxCUI 199904, 211777UNII V1L22WVE2S
Pharmacologic class: 5-Lipoxygenase Inhibitor

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N410122090112 followed by a unit qualifier and the quantity

Package 10122-0901-12. 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 Nov 30, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE ZYFLO is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 10122-901

What is NDC 10122-901?: 10122-901 is the product NDC for Zyflo (zileuton), Zileuton 600 mg/1 tablet, listed with the FDA by Chiesi USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Zyflo (Zileuton).
What is the active ingredient?: Zileuton.
Who is the labeler?: Chiesi USA, Inc., NDC labeler code 10122. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Zyflo?: 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.

Zyflo (Zileuton) NDC 10122-901