Rosuvastatin Calcium

Product NDC
0904-6780
11-digit product format
009046780
Labeler code
0904
Product ID
0904-6780_4123d755-6542-42b3-ae0b-9df6c409efdd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA201619
Marketing category
ANDA
Marketing start
2016-10-31
Marketing end
0000-00-00
Substance
ROSUVASTATIN CALCIUM
Active strength
20 mg/1
Pharmacologic classes
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 NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6780-61EA - Each0904-6780e1005061-911b-40a3-a93f-0bf94d5a45fa12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6780ROSUVASTATIN CALCIUM TABLET, COATED [MAJOR PHARMACEUTICALS]11Legacy NDC20250430_8f2cda59-2bdc-49de-98cd-53ac6b0decdb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6780-6100904678061100 BLISTER PACK in 1 CARTON (0904-6780-61) > 1 TABLET, COATED in 1 BLISTER PACK100 blister pack2016-10-310000-00-00NoNoCurrent