Zafirlukast

Product NDC: 42291-971
11-digit product format: 422910971
Labeler code: 42291
Product ID: 42291-971_3b3c7fd6-2d93-6df8-e063-6294a90a841f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zafirlukast
Dosage form: TABLET, COATED
Route: ORAL
Labeler: AvKARE
Application: NDA020547
Marketing category: NDA
Marketing start: 2023-04-05
Substance: ZAFIRLUKAST
Active strength: 20 mg/1
Pharmacologic classes: Cytochrome P450 2C9 Inhibitors [MoA], Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 42291-971_3b3c7fd6-2d93-6df8-e063-6294a90a841f
SPL ID: 3b3c7fd6-2d93-6df8-e063-6294a90a841f
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Zafirlukast
Generic name: zafirlukast
Dosage form: TABLET, COATED
Route: ORAL
Marketing start: 2023-04-05
Marketing category: NDA
Application number: NDA020547
Pharmacologic classes: Cytochrome P450 2C9 Inhibitors [MoA]; Leukotriene Receptor Antagonist [EPC]; Leukotriene Receptor Antagonists [MoA]
Listing expiration: 2026-12-31

Ingredient	Strength
ZAFIRLUKAST	20 mg/1

Package NDC	Description	Marketing start	Sample
42291-971-60	60 TABLET, COATED in 1 BOTTLE (42291-971-60)	2023-04-05	No

UNII	Preferred term	Registry number	Matched term
XZ629S5L50	ZAFIRLUKAST	107753-78-6	ZAFIRLUKAST

Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
42291-971-60	42291097160	60 TABLET, COATED in 1 BOTTLE (42291-971-60)	2023-04-05	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Zafirlulkast Tablets Rx Only	AvKARE	2025-07-31	HUMAN PRESCRIPTION DRUG LABEL	3