EZETIMIBE
- Product NDC
- 31722-628
- 11-digit product format
- 317220628
- Labeler code
- 31722
- Product ID
- 31722-628_1d93c66e-c5ea-de6f-e063-6294a90acfb8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- EZETIMIBE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA210859
- Marketing category
- ANDA
- Marketing start
- 2022-07-26
- 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#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-628 | EZETIMIBE (EZETIMIBE) TABLET [CAMBER PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 9 package rows | 20240720_c07fe2e0-dad4-48b5-8a07-7d57a4035ccd.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 |
|---|
| 31722-628-01 | 31722062801 | 100 TABLET in 1 BOTTLE (31722-628-01) | 100 tablet | 2022-07-26 | 0000-00-00 | No | No | Current |
| 31722-628-05 | 31722062805 | 500 TABLET in 1 BOTTLE (31722-628-05) | 500 tablet | 2023-09-25 | | No | No | Historical |
| 31722-628-10 | 31722062810 | 1000 TABLET in 1 BOTTLE (31722-628-10) | 1000 tablet | 2023-09-25 | | No | No | Historical |
| 31722-628-30 | 31722062830 | 30 TABLET in 1 BOTTLE (31722-628-30) | 30 tablet | 2022-07-26 | 0000-00-00 | No | No | Current |
| 31722-628-31 | 31722062831 | 100 BLISTER PACK in 1 CARTON (31722-628-31) / 10 TABLET in 1 BLISTER PACK | 100 blister pack | 2022-07-26 | 0000-00-00 | No | No | Current |
| 31722-628-32 | 31722062832 | 70 BLISTER PACK in 1 CARTON (31722-628-32) > 7 TABLET in 1 BLISTER PACK | 70 blister pack | 2022-02-13 | 0000-00-00 | No | No | Current |
| 31722-628-34 | 31722062834 | 100 BLISTER PACK in 1 CARTON (31722-628-34) / 10 TABLET in 1 BLISTER PACK | 100 blister pack | 2022-07-26 | | No | No | Historical |
| 31722-628-90 | 31722062890 | 90 TABLET in 1 BOTTLE (31722-628-90) | 90 tablet | 2022-07-26 | 0000-00-00 | No | No | Current |