FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
71335-1098
11-digit product format
713351098
Labeler code
71335
Product ID
71335-1098_1700684a-fd20-42ea-abd3-939b610ea807
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208898
Marketing category
ANDA
Marketing start
2017-11-22
Substance
ROSUVASTATIN CALCIUM
Active strength
20 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 CALCIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83MVU38M7Q
Rxcui859751

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
71335-1098-1Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED30102
71335-1098-2Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED90102
71335-1098-3Rosuvastatin Calcium28 in 1 BOTTLETABLET, FILM COATED28102
71335-1098-4Rosuvastatin Calcium60 in 1 BOTTLETABLET, FILM COATED60102
71335-1098-5Rosuvastatin Calcium180 in 1 BOTTLETABLET, FILM COATED180102
71335-1098-6Rosuvastatin Calcium120 in 1 BOTTLETABLET, FILM COATED120102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1098ROSUVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 6 package rows20240830_a9a5641f-9b7d-4a98-8dac-a3c53dde861f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859751rosuvastatin calcium 20 MG Oral TabletPSNa9a5641f-9b7d-4a98-8dac-a3c53dde861f102
859751rosuvastatin calcium 20 MG Oral TabletSCDa9a5641f-9b7d-4a98-8dac-a3c53dde861f102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1098-17133510980130 TABLET, FILM COATED in 1 BOTTLE (71335-1098-1) 2022-02-090000-00-00NoNoCurrent
71335-1098-27133510980290 TABLET, FILM COATED in 1 BOTTLE (71335-1098-2) 2022-02-090000-00-00NoNoCurrent
71335-1098-37133510980328 TABLET, FILM COATED in 1 BOTTLE (71335-1098-3) 2022-02-090000-00-00NoNoCurrent
71335-1098-47133510980460 TABLET, FILM COATED in 1 BOTTLE (71335-1098-4) 2022-02-090000-00-00NoNoCurrent
71335-1098-571335109805180 TABLET, FILM COATED in 1 BOTTLE (71335-1098-5) 2022-02-090000-00-00NoNoCurrent
71335-1098-671335109806120 TABLET, FILM COATED in 1 BOTTLE (71335-1098-6) 2022-02-090000-00-00NoNoCurrent