Ezetimibe and Simvastatin
- Product NDC
- 42291-081
- 11-digit product format
- 422910081
- Labeler code
- 42291
- Product ID
- 42291-081_ea379ef9-ddc8-ef34-e053-2995a90a6db3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ezetimibe and Simvastatin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA208831
- Marketing category
- ANDA
- Marketing start
- 2022-10-04
- Marketing end
- 0000-00-00
- Substance
- EZETIMIBE; SIMVASTATIN
- Active strength
- 10 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-081 | EZETIMIBE AND SIMVASTATIN TABLET [AVKARE] | 2 | Legacy NDC | 20240110_ea37adb0-a162-42d9-e053-2995a90aeaad.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42291-081-50 | 42291008150 | 500 TABLET in 1 BOTTLE (42291-081-50) | 500 tablet | 2022-10-04 | 0000-00-00 | No | No | Current |