Zafirlukast
- Product NDC
- 16571-654
- 11-digit product format
- 165710654
- Labeler code
- 16571
- Product ID
- 16571-654_4ffc2ac9-b6e5-43b3-b7e5-747face7b214
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zafirlukast
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharmaceuticals, Inc.
- Application
- ANDA204928
- Marketing category
- ANDA
- Marketing start
- 2022-08-25
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16571-654-06 | 16571065406 | 60 TABLET in 1 BOTTLE, PLASTIC (16571-654-06) | 60 tablet | 2022-08-25 | 0000-00-00 | No | No | Current |