Zileuton
- Product NDC
- 64380-189
- 11-digit product format
- 643800189
- Labeler code
- 64380
- Product ID
- 64380-189_4bb0aa92-80d2-4cbc-9261-012f3b5eb1c1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zileuton
- Dosage form
- TABLET, MULTILAYER, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA212670
- Marketing category
- ANDA
- Marketing start
- 2022-10-15
- Substance
- ZILEUTON
- Active strength
- 600 mg/1
- Pharmacologic classes
- 5-Lipoxygenase Inhibitor [EPC], 5-Lipoxygenase Inhibitors [MoA], Decreased Leukotriene Production [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zileuton
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZILEUTON | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V1L22WVE2S |
| Rxcui | 730834 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64380-189-01 | Zileuton | 120 in 1 BOTTLE | TABLET, MULTILAYER, EXTENDED REL | 120 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64380-189 | ZILEUTON TABLET, MULTILAYER, EXTENDED RELEASE [STRIDES PHARMA SCIENCE LIMITED] | 2 | Current NDC, Legacy NDC, 1 package rows | 20221015_a826d16f-df07-447b-b050-b9a02ea1f89e.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 |
|---|
| 64380-189-01 | 64380018901 | 120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (64380-189-01) | 2022-10-15 | 0000-00-00 | No | No | Current |