ROSUVASTATIN CALCIUM

Product NDC
68180-733
11-digit product format
681800733
Labeler code
68180
Product ID
68180-733_abb25f86-915e-4e61-8221-cfebb4f71068
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROSUVASTATIN CALCIUM
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA205587
Marketing category
ANDA
Marketing start
2017-07-31
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
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-733-02ROSUVASTATIN CALCIUM500 in 1 BOTTLETABLET5007
68180-733-06ROSUVASTATIN CALCIUM30 in 1 BOTTLETABLET307
68180-733-09ROSUVASTATIN CALCIUM90 in 1 BOTTLETABLET907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-733ROSUVASTATIN CALCIUM TABLET [LUPIN PHARMACEUTICALS, INC.]7Legacy NDC, 3 package rows20181026_f68aa10b-d6bd-4fb4-a652-fad85efdaabd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSNf68aa10b-d6bd-4fb4-a652-fad85efdaabd7
859751rosuvastatin calcium 20 MG Oral TabletPSNf68aa10b-d6bd-4fb4-a652-fad85efdaabd7
859419rosuvastatin calcium 40 MG Oral TabletPSNf68aa10b-d6bd-4fb4-a652-fad85efdaabd7
859424rosuvastatin calcium 5 MG Oral TabletPSNf68aa10b-d6bd-4fb4-a652-fad85efdaabd7
859747rosuvastatin calcium 10 MG Oral TabletSCDf68aa10b-d6bd-4fb4-a652-fad85efdaabd7
859751rosuvastatin calcium 20 MG Oral TabletSCDf68aa10b-d6bd-4fb4-a652-fad85efdaabd7
859419rosuvastatin calcium 40 MG Oral TabletSCDf68aa10b-d6bd-4fb4-a652-fad85efdaabd7
859424rosuvastatin calcium 5 MG Oral TabletSCDf68aa10b-d6bd-4fb4-a652-fad85efdaabd7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68180-733-0268180073302500 in 1 BOTTLEHistorical
68180-733-066818007330630 in 1 BOTTLEHistorical
68180-733-096818007330990 in 1 BOTTLEHistorical