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NDC 64980-0206-12 Zileuton 600 mg/1 Details
Zileuton 600 mg/1
Zileuton is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Rising Pharmaceuticals, Inc.. The primary component is ZILEUTON.
MedlinePlus Drug Summary
Zileuton is used to prevent wheezing, shortness of breath, coughing, and chest tightness due to asthma. Zileuton is not used to treat an asthma attack (sudden episode of shortness of breath, wheezing, and coughing) that has already started. Zileuton belongs to a class of medications called leukotriene synthesis inhibitors. It works by stopping the formation of certain natural substances that cause swelling, tightening, and mucus production in the airways.
Related Packages: 64980-0206-12Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Zileuton
Product Information
| NDC | 64980-0206 |
|---|---|
| Product ID | 64980-206_593fedfc-4dc8-496d-b44c-d8febcc025ef |
| Associated GPIs | 44504085007420 |
| GCN Sequence Number | 063062 |
| GCN Sequence Number Description | zileuton TBMP 12HR 600 MG ORAL |
| HIC3 | Z4E |
| HIC3 Description | 5-LIPOXYGENASE INHIBITORS |
| GCN | 98822 |
| HICL Sequence Number | 012321 |
| HICL Sequence Number Description | ZILEUTON |
| Brand/Generic | Generic |
| Proprietary Name | Zileuton |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Zileuton |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 600 |
| Active Ingredient Units | mg/1 |
| Substance Name | ZILEUTON |
| Labeler Name | Rising Pharmaceuticals, Inc. |
| Pharmaceutical Class | 5-Lipoxygenase Inhibitor [EPC], 5-Lipoxygenase Inhibitors [MoA], Decreased Leukotriene Production [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA204929 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 64980-0206-12 (64980020612)
| NDC Package Code | 64980-206-12 |
|---|---|
| Billing NDC | 64980020612 |
| Package | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-206-12) |
| Marketing Start Date | 2017-03-21 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 10.0166 |
| Pricing Unit | EA |
| Effective Date | 2022-11-23 |
| NDC Description | ZILEUTON ER 600 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2022-11-23 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
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