What is NDC 64380-189?

64380-189 is the product NDC for Zileuton, Zileuton 600 mg/1 tablet, multilayer, extended release, listed with the FDA by Strides Pharma Science Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Strides Pharma Science Limited, NDC labeler code 64380. 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 64380-189 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)64380-189Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64380-0189Add 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
64380-189-01	64380018901	120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (64380-189-01)Marketed from Oct 15, 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, Multilayer, Extended release
Route: Oral
Labeler: Strides Pharma Science LimitedNDC labeler code 64380
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212670
Marketing start: Oct 15, 2022
Listing expires: Dec 31, 2026
Other FDA classes: 5-Lipoxygenase Inhibitors (Mechanism)Decreased Leukotriene Production (Physiologic effect)
Identifiers: Product ID 64380-189_4bb0aa92-80d2-4cbc-9261-012f3b5eb1c1SPL ID 4bb0aa92-80d2-4cbc-9261-012f3b5eb1c1SPL set ID a826d16f-df07-447b-b050-b9a02ea1f89eRxCUI 730834UNII V1L22WVE2SUPC 0364380189015
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

N464380018901 followed by a unit qualifier and the quantity

Package 64380-0189-01. 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 Jul 29, 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 tablets 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 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 64380-189

What is NDC 64380-189?: 64380-189 is the product NDC for Zileuton, Zileuton 600 mg/1 tablet, multilayer, extended release, listed with the FDA by Strides Pharma Science Limited. 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?: Strides Pharma Science Limited, NDC labeler code 64380. 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, 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
Zileuton	Zileuton 600 mg/1	Tablet, Extended releaseOral	Rising Pharma Holdings, Inc.	64980-206	64980-0206-12

Other NDCs under ANDA 212670

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

FDA NDC Directory listings under ANDA 212670
Product	Strength	Form · route	Labeler	Product NDC
Zileuton	Zileuton 600 mg/1	Tablet, Multilayer, Extended releaseOral	Golden State Medical Supply, Inc.	51407-741