Ezetimibe
- Product NDC
- 76333-170
- 11-digit product format
- 763330170
- Labeler code
- 76333
- Product ID
- 76333-170_161b88d8-6679-e793-e063-6394a90a481b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ezetimibe
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Orient Pharma Co., Ltd.
- Application
- ANDA215693
- Marketing category
- ANDA
- Marketing start
- 2022-06-30
- 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 |
|---|
| 76333-170-12 | Ezetimibe | 1000 in 1 BOTTLE | TABLET | 1000 | | 7 |
| 76333-170-13 | Ezetimibe | 500 in 1 BOTTLE | TABLET | 500 | | 7 |
| 76333-170-14 | Ezetimibe | 90 in 1 BOTTLE | TABLET | 90 | | 7 |
| 76333-170-15 | Ezetimibe | 30 in 1 BOTTLE | TABLET | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76333-170 | EZETIMIBE TABLET [ORIENT PHARMA CO., LTD.] | 7 | Current NDC, Legacy NDC, 4 package rows | 20240417_b6e77d9b-a553-63e0-e053-2a95a90a18fe.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 |
|---|
| 76333-170-12 | 76333017012 | 1000 TABLET in 1 BOTTLE (76333-170-12) | 1000 tablet | 2023-11-13 | | No | No | Current |
| 76333-170-13 | 76333017013 | 500 TABLET in 1 BOTTLE (76333-170-13) | 500 tablet | 2023-11-13 | | No | No | Current |
| 76333-170-14 | 76333017014 | 90 TABLET in 1 BOTTLE (76333-170-14) | 90 tablet | 2023-11-13 | | No | No | Current |
| 76333-170-15 | 76333017015 | 30 TABLET in 1 BOTTLE (76333-170-15) | 30 tablet | 2022-06-30 | 0000-00-00 | No | No | Current |