Zafirlukast
- Product NDC
- 59651-291
- 11-digit product format
- 596510291
- Labeler code
- 59651
- Product ID
- 59651-291_8bdb47c5-9d19-4d59-94c8-62c117525e7f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zafirlukast
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA213163
- Marketing category
- ANDA
- Marketing start
- 2023-11-27
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zafirlukast
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZAFIRLUKAST | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | XZ629S5L50 |
| Rxcui | 199655, 313758 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-291-60 | Zafirlukast | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-291 | ZAFIRLUKAST TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | Current NDC, 1 package rows | 20231204_8bdb47c5-9d19-4d59-94c8-62c117525e7f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-291-60 | 59651029160 | 60 TABLET, FILM COATED in 1 BOTTLE (59651-291-60) | 2023-11-27 | No | No | Current |
| 59651-291-73 | 59651029173 | 7000 TABLET, FILM COATED in 1 BAG (59651-291-73) | 27-NOV-23 | | | Current |