What is NDC 64980-206?

64980-206 is the product NDC for Zileuton, Zileuton 600 mg/1 tablet, extended release, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Rising Pharma Holdings, Inc., NDC labeler code 64980. 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 64980-206 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)64980-206Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64980-0206Add 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
64980-206-12	64980020612	120 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-206-12)Marketed from Mar 21, 2017

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, Extended release
Route: Oral
Labeler: Rising Pharma Holdings, Inc.NDC labeler code 64980
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204929
Marketing start: Mar 21, 2017
Listing expires: Dec 31, 2026
Other FDA classes: 5-Lipoxygenase Inhibitors (Mechanism)Decreased Leukotriene Production (Physiologic effect)
Identifiers: Product ID 64980-206_984587a3-4875-4ad3-af6e-11b90fe705a8SPL ID 984587a3-4875-4ad3-af6e-11b90fe705a8SPL set ID fd382540-b390-4e86-a94a-988ea89c93a8RxCUI 730834UNII 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

N464980020612 followed by a unit qualifier and the quantity

Package 64980-0206-12. 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 May 15, 2024.

Indications (excerpt from the label)

Zileuton Extended-Release Tablets is 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 Tablets can be continued during acute exacerbations of asthma. Zileuton Extended-Release Tablets is 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 Tablets 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 64980-206

What is NDC 64980-206?: 64980-206 is the product NDC for Zileuton, Zileuton 600 mg/1 tablet, extended release, listed with the FDA by Rising Pharma Holdings, 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?: Rising Pharma Holdings, Inc., NDC labeler code 64980. 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, Film coated, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-044	31722-0044-12
Zileuton	Zileuton 600 mg/1	Tablet, Multilayer, Extended releaseOral	Golden State Medical Supply, Inc.	51407-741	51407-0741-12