Ezetimibe and Simvastatin
- Product NDC
- 70518-1955
- 11-digit product format
- 705181955
- Labeler code
- 70518
- Product ID
- 70518-1955_eb3baffa-a9dc-668e-e053-2a95a90a550a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ezetimibe and Simvastatin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA209222
- Marketing category
- ANDA
- Marketing start
- 2019-03-13
- 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 |
|---|
| 70518-1955 | EZETIMIBE AND SIMVASTATIN TABLET [REMEDYREPACK INC.] | 12 | Legacy NDC | 20250305_ffc78862-e707-4415-9f52-21e393192ad7.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-1955-0 | 70518195500 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-1955-0) | 90 tablet | 2019-03-13 | 0000-00-00 | No | No | Current |