Rosuvastatin Calcium

Product NDC
81288-751
11-digit product format
812880751
Labeler code
81288
Product ID
81288-751_e48eb21b-bb32-4230-b985-d9dcb18960b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
EMC PHARMA, LLC
Application
ANDA207375
Marketing category
ANDA
Marketing start
2022-07-28
Marketing end
0000-00-00
Substance
ROSUVASTATIN CALCIUM
Active strength
10 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81288-751-90EA - Each81288-751a039e01a-16b7-4731-be45-5356dad8ef5f12023-02-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
81288-751-908128807519090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (81288-751-90) 2022-07-280000-00-00NoNoCurrent