Zileuton
- Product NDC
- 49884-723
- 11-digit product format
- 498840723
- Labeler code
- 49884
- Product ID
- 49884-723_db5770ae-8b7f-4e3f-a7ae-2ca285fcc6ba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zileuton
- Dosage form
- TABLET, MULTILAYER, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Par Pharmaceutical, Inc.
- Application
- ANDA212670
- Marketing category
- ANDA
- Marketing start
- 2020-01-09
- Marketing end
- 2023-11-30
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 49884-723-08 | 49884072308 | 120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (49884-723-08) | 2020-01-09 | 0000-00-00 | No | No | Current |