Zafirlukast
- Product NDC
- 59651-291
- 11-digit product format
- 596510291
- Labeler code
- 59651
- Product ID
- 59651-291_8bdb47c5-9d19-4d59-94c8-62c117525e7f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zafirlukast
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA213163
- Marketing category
- ANDA
- Marketing start
- 2023-11-27
- 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 |
|---|
| 59651-291-60 | 59651029160 | 60 TABLET, FILM COATED in 1 BOTTLE (59651-291-60) | 2023-11-27 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Zafirlukast Tablets Rx only | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 2023-12-01 | Human Prescription Drug Label | 1 |