ROSZET

Product NDC: 70661-001
11-digit product format: 706610001
Labeler code: 70661
Product ID: 70661-001_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: 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70661-001-30	EA - Each	70661-001	5fcf9339-9cda-410c-9551-b1f39c65465d	1	2021-05-05

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
83MVU38M7Q	ROSUVASTATIN CALCIUM	147098-20-2	ROSUVASTATIN CALCIUM
EOR26LQQ24	EZETIMIBE	163222-33-1	EZETIMIBE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70661-001-30	70661000130	30 TABLET in 1 BOTTLE (70661-001-30)	30 tablet	2021-05-10	0000-00-00	No	No	Current