ROSUVASTATIN AND EZETIMIBE

Product NDC: 82120-127
11-digit product format: 821200127
Labeler code: 82120
Product ID: 82120-127_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: 21 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: 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
82120-127-30	EA - Each	82120-127	52e215c7-cc56-4a18-bc3e-30c9f0461a6a	1	2021-10-08

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
82120-127-30	82120012730	30 TABLET in 1 BOTTLE (82120-127-30)	30 tablet	2021-08-15	0000-00-00	No	No	Current