Zafirlukast
- Product NDC
- 42291-970
- 11-digit product format
- 422910970
- Labeler code
- 42291
- Product ID
- 42291-970_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
- 10 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| XZ629S5L50 | ZAFIRLUKAST | 107753-78-6 | ZAFIRLUKAST |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42291-970-60 | 42291097060 | 60 TABLET, COATED in 1 BOTTLE (42291-970-60) | 2023-04-05 | No | No | Historical |