ezetimibe
- Product NDC
- 82009-024
- 11-digit product format
- 820090024
- Labeler code
- 82009
- Product ID
- 82009-024_98acb755-ad5c-414a-b9e9-6cd30c10a2e7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ezetimibe
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Quallent Pharmaceuticals Health LLC
- Application
- ANDA204331
- Marketing category
- ANDA
- Marketing start
- 2022-08-20
- Substance
- EZETIMIBE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ezetimibe
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EZETIMIBE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | EOR26LQQ24 |
| Rxcui | 349556 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82009-024-05 | ezetimibe | 500 in 1 BOTTLE | TABLET | 500 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82009-024 | EZETIMIBE TABLET [QUALLENT PHARMACEUTICALS HEALTH LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240322_68247ce8-e812-42f2-a3ba-0f6e49acca63.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 82009-024-05 | 82009002405 | 500 TABLET in 1 BOTTLE (82009-024-05) | 500 tablet | 2022-08-20 | 0000-00-00 | No | No | Current |