What is NDC 31722-044?

31722-044 is the product NDC for Zileuton, Zileuton 600 mg/1 tablet, film coated, extended release, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Camber Pharmaceuticals, Inc., NDC labeler code 31722. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Zileuton?

4 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Zileuton NDC 31722-044 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)31722-044Labeler and product segments. Claims need a package NDC.

Product NDC at billing width31722-0044Add 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
31722-044-12	31722004412	120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-044-12)Marketed from Oct 11, 2022

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): Zileuton
Generic name (nonproprietary): zileuton
Active ingredients: Zileuton — 600 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Camber Pharmaceuticals, Inc.NDC labeler code 31722
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215742
Marketing start: Oct 11, 2022
Listing expires: Dec 31, 2026
Other FDA classes: 5-Lipoxygenase Inhibitors (Mechanism)Decreased Leukotriene Production (Physiologic effect)
Identifiers: Product ID 31722-044_eaf892a4-41c4-70e0-e053-2995a90a2079SPL ID eaf892a4-41c4-70e0-e053-2995a90a2079SPL set ID 94313e24-9534-4b6c-b374-c436c4916303RxCUI 730834UNII V1L22WVE2SUPC 0331722044127
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

N431722004412 followed by a unit qualifier and the quantity

Package 31722-0044-12. 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 Oct 14, 2022.

Indications (excerpt from the label)

Zileuton extended-release tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. Zileuton extended-release tablets are not indicated for use in the reversal of bronchospasm in acute asthma attacks. Therapy with zileuton extended-release tablet can be continued during acute exacerbations of asthma. Zileuton extended-release tablets are a leukotriene synthesis inhibitor indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. ( 1 ) Do not use zileuton extended-release tablet to treat an acute asthma attack. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 31722-044

What is NDC 31722-044?: 31722-044 is the product NDC for Zileuton, Zileuton 600 mg/1 tablet, film coated, extended release, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Zileuton.
What is the active ingredient?: Zileuton.
Who is the labeler?: Camber Pharmaceuticals, Inc., NDC labeler code 31722. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Zileuton?: 4 other product NDCs are listed under this name. See all Zileuton 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 Zileuton NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Zileuton	Zileuton 600 mg/1	Tablet, Film coated, Extended releaseOral	NorthStar RxLLC	72603-246	72603-0246-01
Zileuton	Zileuton 600 mg/1	Tablet, Multilayer, Extended releaseOral	Strides Pharma Science Limited	64380-189	64380-0189-01
Zileuton	Zileuton 600 mg/1	Tablet, Multilayer, Extended releaseOral	Golden State Medical Supply, Inc.	51407-741	51407-0741-12
Zileuton	Zileuton 600 mg/1	Tablet, Extended releaseOral	Rising Pharma Holdings, Inc.	64980-206	64980-0206-12

Other NDCs under ANDA 215742

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

FDA NDC Directory listings under ANDA 215742
Product	Strength	Form · route	Labeler	Product NDC
Zileuton	Zileuton 600 mg/1	Tablet, Film coated, Extended releaseOral	NorthStar RxLLC	72603-246