Zafirlukast
- Product NDC
- 50268-805
- 11-digit product format
- 502680805
- Labeler code
- 50268
- Product ID
- 50268-805_d5e0cbd6-9b29-9baa-e053-2995a90a02a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zafirlukast
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA090372
- Marketing category
- ANDA
- Marketing start
- 2017-09-15
- Marketing end
- 0000-00-00
- 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
- 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 |
|---|
| 50268-805-12 | 50268080512 | 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-805-12) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-805-11) | 20 blister pack | 2017-09-15 | 0000-00-00 | No | No | Current |