ROSUVASTATIN AND EZETIMIBE
- Product NDC
- 82120-125
- 11-digit product format
- 821200125
- Labeler code
- 82120
- Product ID
- 82120-125_e790e881-a4ea-43df-b997-f10fc06933be
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- rosuvastatin and ezetimibe
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- SCOV3 LLC
- Application
- NDA213072
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2021-08-15
- Marketing end
- 0000-00-00
- Substance
- ROSUVASTATIN CALCIUM; EZETIMIBE
- Active strength
- 5 mg/1; mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA],Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 82120-125-30 | 82120012530 | 30 TABLET in 1 BOTTLE (82120-125-30) | 30 tablet | 2021-08-15 | 0000-00-00 | No | No | Current |