Zileuton
- Product NDC
- 66993-485
- 11-digit product format
- 669930485
- Labeler code
- 66993
- Product ID
- 66993-485_5150b929-6f54-4047-9384-ba9a0d4ef46f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zileuton
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Prasco, LLC
- Application
- NDA022052
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2017-03-29
- Marketing end
- 0000-00-00
- Substance
- ZILEUTON
- Active strength
- 600 mg/1
- Pharmacologic classes
- 5-Lipoxygenase Inhibitors [MoA],Decreased Leukotriene Production [PE],5-Lipoxygenase Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 |
|---|
| 66993-485-32 | 66993048532 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (66993-485-32) | 2017-03-29 | 0000-00-00 | No | No | Current |