Zileuton
- Product NDC
- 69339-130
- 11-digit product format
- 693390130
- Labeler code
- 69339
- Product ID
- 69339-130_f1429302-86df-1568-e053-2995a90a9b93
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zileuton
- Dosage form
- TABLET, MULTILAYER, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- DASH Pharmaceutical LLC
- Application
- ANDA211390
- Marketing category
- ANDA
- Marketing start
- 2020-10-23
- Marketing end
- 0000-00-00
- 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
- 2024-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69339-130-12 | 69339013012 | 120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (69339-130-12) | 2020-10-23 | 0000-00-00 | No | No | Current |