Zileuton
- Product NDC
- 64980-206
- 11-digit product format
- 649800206
- Labeler code
- 64980
- Product ID
- 64980-206_984587a3-4875-4ad3-af6e-11b90fe705a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zileuton
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA204929
- Marketing category
- ANDA
- Marketing start
- 2017-03-21
- 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 |
|---|
| 64980-206-12 | Zileuton | 120 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 120 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64980-206 | ZILEUTON TABLET, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.] | 7 | Current NDC, Legacy NDC, 1 package rows | 20240524_fd382540-b390-4e86-a94a-988ea89c93a8.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 |
|---|
| 64980-206-12 | 64980020612 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-206-12) | 2017-03-21 | 0000-00-00 | No | No | Current |