Zileuton
- Product NDC
- 72603-246
- 11-digit product format
- 726030246
- Labeler code
- 72603
- Product ID
- 72603-246_17766300-70b8-ee56-e063-6294a90aeb1a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zileuton
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- NorthStar RxLLC
- Application
- ANDA215742
- Marketing category
- ANDA
- Marketing start
- 2024-05-01
- 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 |
|---|
| 72603-246-01 | Zileuton | 120 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 120 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72603-246 | ZILEUTON (ZILEUTON) TABLET, FILM COATED, EXTENDED RELEASE [NORTHSTAR RXLLC] | 1 | Current NDC, 1 package rows | 20240503_bc29c998-1324-46aa-8386-e5b2fc9e0b16.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72603-246-01 | 72603024601 | 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72603-246-01) | 2024-05-01 | No | No | Historical |