ROSZET
- Product NDC
- 70661-004
- 11-digit product format
- 706610004
- Labeler code
- 70661
- Product ID
- 70661-004_a3a6aab1-44b6-4670-bbdc-516f33274d99
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- (rosuvastatin and ezetimibe)
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Althera Pharmaceuticals LLC
- Application
- NDA213072
- Marketing category
- NDA
- Marketing start
- 2021-05-10
- Marketing end
- 0000-00-00
- Substance
- ROSUVASTATIN CALCIUM; EZETIMIBE
- Active strength
- 42 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 |
|---|
| 70661-004-10 | 70661000410 | 10 TABLET in 1 BOTTLE (70661-004-10) | 10 tablet | 2021-09-15 | 0000-00-00 | Yes | No | Current |
| 70661-004-30 | 70661000430 | 30 TABLET in 1 BOTTLE (70661-004-30) | 30 tablet | 2021-05-10 | 0000-00-00 | No | No | Current |