Ezetimibe
- Product NDC
- 82804-064
- 11-digit product format
- 828040064
- Labeler code
- 82804
- Product ID
- 82804-064_8b128e52-5d0d-4536-aa1f-be192d0989ad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ezetimibe
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA209838
- Marketing category
- ANDA
- Marketing start
- 2017-08-25
- 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 |
|---|
| 82804-064-30 | Ezetimibe | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 82804-064-60 | Ezetimibe | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 82804-064-90 | Ezetimibe | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-064 | EZETIMIBE TABLET [PROFICIENT RX LP] | 1 | Current NDC, 3 package rows | 20240206_8b128e52-5d0d-4536-aa1f-be192d0989ad.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 |
|---|
| 82804-064-30 | 82804006430 | 30 TABLET in 1 BOTTLE (82804-064-30) | 30 tablet | 2024-01-31 | No | No | Current |
| 82804-064-60 | 82804006460 | 60 TABLET in 1 BOTTLE (82804-064-60) | 60 tablet | 2024-01-31 | No | No | Current |
| 82804-064-90 | 82804006490 | 90 TABLET in 1 BOTTLE (82804-064-90) | 90 tablet | 2024-01-31 | No | No | Current |