Accolate
- Product NDC
- 49884-589
- 11-digit product format
- 498840589
- Labeler code
- 49884
- Product ID
- 49884-589_1562c939-2d4d-452f-add4-2e24a29464cd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zafirlukast
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Par Pharmaceutical, Inc.
- Application
- NDA020547
- Marketing category
- NDA
- Marketing start
- 2015-11-01
- Marketing end
- 2024-04-30
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 49884-589-02 | 49884058902 | 60 TABLET, COATED in 1 BOTTLE (49884-589-02) | 2015-11-01 | 2024-04-30 | No | No | Current |