Rosuvastatin Calcium

Product NDC
45865-893
11-digit product format
458650893
Labeler code
45865
Product ID
45865-893_7df002ca-e0ad-24fe-e053-2991aa0ab75f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA079166
Marketing category
ANDA
Marketing start
2016-08-18
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
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-893-49Rosuvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED1001
45865-893-60Rosuvastatin Calcium60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-893ROSUVASTATIN CALCIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 2 package rows20181227_7defeea4-b909-bd8b-e053-2a91aa0afedd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN7defeea4-b909-bd8b-e053-2a91aa0afedd1
859747rosuvastatin calcium 10 MG Oral TabletSCD7defeea4-b909-bd8b-e053-2a91aa0afedd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
45865-893-4945865089349100 in 1 BOTTLEHistorical
45865-893-604586508936060 in 1 BOTTLEHistorical