Ezetimibe and Simvastatin
- Product NDC
- 67877-508
- 11-digit product format
- 678770508
- Labeler code
- 67877
- Product ID
- 67877-508_ca1a42e2-f129-462a-8e87-a034da71862b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ezetimibe and Simvastatin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA209222
- Marketing category
- ANDA
- Marketing start
- 2017-12-24
- Substance
- EZETIMIBE; SIMVASTATIN
- Active strength
- 10; 20 mg/1; mg/1
- Pharmacologic classes
- Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ezetimibe and Simvastatin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EZETIMIBE | 10 mg/1 |
| SIMVASTATIN | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AGG2FN16EV, EOR26LQQ24 |
| Rxcui | 476345, 476349, 476350, 476351 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67877-508-01 | Ezetimibe and Simvastatin | 1000 in 1 BOTTLE | TABLET | 1000 | | 16 |
| 67877-508-30 | Ezetimibe and Simvastatin | 30 in 1 BOTTLE | TABLET | 30 | | 16 |
| 67877-508-33 | Ezetimibe and Simvastatin | 10 in 1 BLISTER PACK | TABLET | 10 | | 16 |
| 67877-508-38 | Ezetimibe and Simvastatin | 10 in 1 CARTON | TABLET | 10 | | 16 |
| 67877-508-90 | Ezetimibe and Simvastatin | 90 in 1 BOTTLE | TABLET | 90 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-508 | EZETIMIBE AND SIMVASTATIN TABLET [ASCEND LABORATORIES, LLC] | 16 | Current NDC, Legacy NDC, 5 package rows | 20250510_c90e8c96-e130-42d7-bf0d-5833652e40d5.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 |
|---|
| 67877-508-01 | 67877050801 | 1000 TABLET in 1 BOTTLE (67877-508-01) | 1000 tablet | 2017-12-24 | 0000-00-00 | No | No | Current |
| 67877-508-30 | 67877050830 | 30 TABLET in 1 BOTTLE (67877-508-30) | 30 tablet | 2017-12-24 | 0000-00-00 | No | No | Current |
| 67877-508-33 | 67877050833 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 67877-508-38 | 67877050838 | 10 BLISTER PACK in 1 CARTON (67877-508-38) / 10 TABLET in 1 BLISTER PACK (67877-508-33) | 10 blister pack | 2017-12-24 | 0000-00-00 | No | No | Current |
| 67877-508-90 | 67877050890 | 90 TABLET in 1 BOTTLE (67877-508-90) | 90 tablet | 2017-12-24 | 0000-00-00 | No | No | Current |