Rosuvastatin Calcium

Product NDC
71335-9640
11-digit product format
713359640
Labeler code
71335
Product ID
71335-9640_3531e516-f3e9-02e7-e063-6294a90a7846
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207408
Marketing category
ANDA
Marketing start
2018-01-08
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rosuvastatin Calcium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN CALCIUM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83MVU38M7Q
Rxcui859747

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
71335-9640-1Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED30102
71335-9640-2Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED90102
71335-9640-3Rosuvastatin Calcium60 in 1 BOTTLETABLET, FILM COATED60102
71335-9640-4Rosuvastatin Calcium120 in 1 BOTTLETABLET, FILM COATED120102
71335-9640-5Rosuvastatin Calcium180 in 1 BOTTLETABLET, FILM COATED180102
71335-9640-6Rosuvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED100102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9640ROSUVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, 6 package rows20250519_4bd37cda-9928-456c-86be-aaccccf2e450.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN4bd37cda-9928-456c-86be-aaccccf2e450102
859747rosuvastatin calcium 10 MG Oral TabletSCD4bd37cda-9928-456c-86be-aaccccf2e450102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9640-17133596400130 TABLET, FILM COATED in 1 BOTTLE (71335-9640-1) 2023-02-06NoNoHistorical
71335-9640-27133596400290 TABLET, FILM COATED in 1 BOTTLE (71335-9640-2) 2023-02-06NoNoHistorical
71335-9640-37133596400360 TABLET, FILM COATED in 1 BOTTLE (71335-9640-3) 2023-02-06NoNoHistorical
71335-9640-471335964004120 TABLET, FILM COATED in 1 BOTTLE (71335-9640-4) 2023-02-06NoNoHistorical
71335-9640-571335964005180 TABLET, FILM COATED in 1 BOTTLE (71335-9640-5) 2023-02-06NoNoHistorical
71335-9640-671335964006100 TABLET, FILM COATED in 1 BOTTLE (71335-9640-6) 2023-02-06NoNoHistorical