ACCOLATE
- Product NDC
- 64380-177
- 11-digit product format
- 643800177
- Labeler code
- 64380
- Product ID
- 64380-177_bd60d8ba-4d06-49e6-898a-0d05de6078c7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zafirlukast
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- NDA020547
- Marketing category
- NDA
- Marketing start
- 2023-01-02
- 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
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64380-177 | ACCOLATE (ZAFIRLUKAST) TABLET, FILM COATED [STRIDES PHARMA SCIENCE LIMITED] | 3 | Legacy NDC | 20250323_3bbd0e85-6014-46cd-a363-60102c4bc5a2.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 64380-177-01 | 64380017701 | 60 TABLET, FILM COATED in 1 BOTTLE (64380-177-01) | 2023-01-02 | 0000-00-00 | No | No | Current |