Zafirlukast
- Product NDC
- 64380-188
- 11-digit product format
- 643800188
- Labeler code
- 64380
- Product ID
- 64380-188_e219b453-57d0-4835-9ac3-4bd73f3b0391
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zafirlukast
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- NDA020547
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2022-08-01
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zafirlukast
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZAFIRLUKAST | 20 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 |
|---|
| 64380-188-01 | Zafirlukast | 60 in 1 BOTTLE | TABLET, COATED | 60 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64380-188 | ZAFIRLUKAST TABLET, COATED [STRIDES PHARMA SCIENCE LIMITED] | 5 | Current NDC, Legacy NDC, 1 package rows | 20230422_baba507f-6557-4551-815c-9ab6606e4ee1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 64380-188-01 | 64380018801 | 60 TABLET, COATED in 1 BOTTLE (64380-188-01) | 2022-08-01 | 0000-00-00 | No | No | Current |