Rosuvastatin Calcium

Product NDC
63187-869
11-digit product format
631870869
Labeler code
63187
Product ID
63187-869_a54f604f-fa5f-4403-ab1a-b58a05a9da45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA079166
Marketing category
ANDA
Marketing start
2016-08-18
Marketing end
0000-00-00
Substance
ROSUVASTATIN CALCIUM
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-869-30EA - Each63187-869ab8c965f-cf7b-437c-9b67-0aba0c6996ec12017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-869ROSUVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP]3Legacy NDC20191113_9e8e4b93-31ef-41eb-a1ed-3d351ae6ca72.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-869-306318708693030 TABLET, FILM COATED in 1 BOTTLE (63187-869-30) 2017-07-030000-00-00NoNoCurrent
63187-869-606318708696060 TABLET, FILM COATED in 1 BOTTLE (63187-869-60) 2017-07-030000-00-00NoNoCurrent
63187-869-906318708699090 TABLET, FILM COATED in 1 BOTTLE (63187-869-90) 2017-07-030000-00-00NoNoCurrent