Ezetimibe
- Product NDC
- 10135-787
- 11-digit product format
- 101350787
- Labeler code
- 10135
- Product ID
- 10135-787_43046023-125e-85f6-e063-6294a90ab8c7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ezetimibe
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals, Inc.
- Application
- ANDA215693
- Marketing category
- ANDA
- Marketing start
- 2024-01-01
- 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 |
|---|
| 10135-787-05 | Ezetimibe | 500 in 1 BOTTLE | TABLET | 500 | | 2 |
| 10135-787-30 | Ezetimibe | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 10135-787-90 | Ezetimibe | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10135-787 | EZETIMIBE TABLET [MARLEX PHARMACEUTICALS, INC.] | 1 | Current NDC, 3 package rows | 20240207_109a22f4-a7cb-96c6-e063-6394a90ad7f6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 10135-787-05 | 10135078705 | 500 TABLET in 1 BOTTLE (10135-787-05) | 500 tablet | 2024-01-01 | No | No | Current |
| 10135-787-30 | 10135078730 | 30 TABLET in 1 BOTTLE (10135-787-30) | 30 tablet | 2024-01-01 | No | No | Current |
| 10135-787-90 | 10135078790 | 90 TABLET in 1 BOTTLE (10135-787-90) | 90 tablet | 2024-01-01 | No | No | Current |