Zafirlukast
- Product NDC
- 31722-008
- 11-digit product format
- 317220008
- Labeler code
- 31722
- Product ID
- 31722-008_5d30ffab-38a1-411d-94ad-0a15c227d882
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zafirlukast
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA212475
- Marketing category
- ANDA
- Marketing start
- 2020-09-10
- 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
- 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 | 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 |
|---|
| 31722-008-01 | Zafirlukast | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 1 |
| 31722-008-01 | Zafirlukast | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 1 |
| 31722-008-05 | Zafirlukast | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 1 |
| 31722-008-60 | 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 |
|---|
| 31722-008 | ZAFIRLUKAST TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | Current NDC, Legacy NDC, 4 package rows | 20200926_5d30ffab-38a1-411d-94ad-0a15c227d882.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 31722-008-01 | 31722000801 | 10 BLISTER PACK in 1 CARTON (31722-008-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2020-09-10 | 0000-00-00 | No | No | Current |
| 31722-008-05 | 31722000805 | 500 TABLET, FILM COATED in 1 BOTTLE (31722-008-05) | | 2020-09-10 | 0000-00-00 | No | No | Current |
| 31722-008-60 | 31722000860 | 60 TABLET, FILM COATED in 1 BOTTLE (31722-008-60) | | 2020-09-10 | 0000-00-00 | No | No | Current |