What is NDC 42291-971?

42291-971 is the product NDC for Zafirlukast, Zafirlukast 20 mg/1 tablet, coated, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.

AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Zafirlukast?

11 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Zafirlukast NDC 42291-971 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-971Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0971Add 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
42291-971-60	42291097160	60 TABLET, COATED in 1 BOTTLE (42291-971-60)Marketed from Apr 5, 2023

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): Zafirlukast
Generic name (nonproprietary): zafirlukast
Active ingredients: Zafirlukast — 20 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: AvKARENDC labeler code 42291
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020547
Marketing start: Apr 5, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C9 Inhibitors (Mechanism)Leukotriene Receptor Antagonists (Mechanism)
Identifiers: Product ID 42291-971_3b3c7fd6-2d93-6df8-e063-6294a90a841fSPL ID 3b3c7fd6-2d93-6df8-e063-6294a90a841fSPL set ID f89a821d-396f-a3aa-e053-6294a90a4577RxCUI 199655, 313758UNII XZ629S5L50
Pharmacologic class: Leukotriene Receptor Antagonist

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

N442291097160 followed by a unit qualifier and the quantity

Package 42291-0971-60. 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 31, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Zafirlukast is indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 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 42291-971

What is NDC 42291-971?: 42291-971 is the product NDC for Zafirlukast, Zafirlukast 20 mg/1 tablet, coated, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Zafirlukast.
What is the active ingredient?: Zafirlukast.
Who is the labeler?: AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Zafirlukast?: 11 other product NDCs are listed under this name. See all Zafirlukast 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 Zafirlukast NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Zafirlukast	Zafirlukast 10 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-291	59651-0291-60
Zafirlukast	Zafirlukast 20 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-292	59651-0292-60
Zafirlukast	Zafirlukast 10 mg/1	Tablet, CoatedOral	AvKARE	42291-970	42291-0970-60
Zafirlukast	Zafirlukast 10 mg/1	Tablet, CoatedOral	Strides Pharma Science Limited	64380-187	64380-0187-01
Zafirlukast	Zafirlukast 20 mg/1	Tablet, CoatedOral	Strides Pharma Science Limited	64380-188	64380-0188-01
Zafirlukast	Zafirlukast 10 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-007	31722-0007-0131722-0007-0531722-0007-60
Zafirlukast	Zafirlukast 20 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-008	31722-0008-0131722-0008-0531722-0008-60
Zafirlukast	Zafirlukast 20 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2361	72162-2361-06
Zafirlukast	Zafirlukast 20 mg/1	Tablet, Film coatedOral	American Health Packaging	68084-059	68084-0059-21
Zafirlukast	Zafirlukast 10 mg/1	Tablet, Film coatedOral	Dr. Reddys Laboratories Limited	55111-625	55111-0625-0155111-0625-0555111-0625-30+2 more

All 12 Zafirlukast NDCs

Other NDCs under NDA 020547

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

FDA NDC Directory listings under NDA 020547
Product	Strength	Form · route	Labeler	Product NDC
Zafirlukast	Zafirlukast 10 mg/1	Tablet, CoatedOral	AvKARE	42291-970
Zafirlukast	Zafirlukast 10 mg/1	Tablet, CoatedOral	Strides Pharma Science Limited	64380-187
Zafirlukast	Zafirlukast 20 mg/1	Tablet, CoatedOral	Strides Pharma Science Limited	64380-188