Zafirlukast
- Product NDC
- 72162-2361
- 11-digit product format
- 721622361
- Labeler code
- 72162
- Product ID
- 72162-2361_50679c31-2161-47a0-a704-13a01760fdbf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zafirlukast
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA212475
- Marketing category
- ANDA
- Marketing start
- 2020-09-10
- 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
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 |
|---|
| 72162-2361-6 | 72162236106 | 60 TABLET, FILM COATED in 1 BOTTLE (72162-2361-6) | 2024-06-28 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Zafirlukast Tablets | Bryant Ranch Prepack | 2024-06-28 | HUMAN PRESCRIPTION DRUG LABEL | 100 |