FDA.reportPublic FDA data

Rosuvastatin calcium

Product NDC
71335-1741
11-digit product format
713351741
Labeler code
71335
Product ID
71335-1741_08f2fc1e-c84b-4a6c-a6a3-f06f03a6196e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207752
Marketing category
ANDA
Marketing start
2016-10-31
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
71335-1741-1Rosuvastatin calcium30 in 1 BOTTLETABLET, FILM COATED30102
71335-1741-2Rosuvastatin calcium90 in 1 BOTTLETABLET, FILM COATED90102
71335-1741-3Rosuvastatin calcium28 in 1 BOTTLETABLET, FILM COATED28102
71335-1741-4Rosuvastatin calcium60 in 1 BOTTLETABLET, FILM COATED60102
71335-1741-5Rosuvastatin calcium180 in 1 BOTTLETABLET, FILM COATED180102
71335-1741-6Rosuvastatin calcium120 in 1 BOTTLETABLET, FILM COATED120102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1741ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM ) TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 6 package rows20231122_eeb492b0-32d8-489e-ab60-6eec52a28efd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859751rosuvastatin calcium 20 MG Oral TabletPSNeeb492b0-32d8-489e-ab60-6eec52a28efd102
859751rosuvastatin calcium 20 MG Oral TabletSCDeeb492b0-32d8-489e-ab60-6eec52a28efd102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1741-17133517410130 TABLET, FILM COATED in 1 BOTTLE (71335-1741-1) 2021-07-260000-00-00NoNoCurrent
71335-1741-27133517410290 TABLET, FILM COATED in 1 BOTTLE (71335-1741-2) 2021-01-060000-00-00NoNoCurrent
71335-1741-37133517410328 TABLET, FILM COATED in 1 BOTTLE (71335-1741-3) 2021-11-300000-00-00NoNoCurrent
71335-1741-47133517410460 TABLET, FILM COATED in 1 BOTTLE (71335-1741-4) 2021-11-300000-00-00NoNoCurrent
71335-1741-571335174105180 TABLET, FILM COATED in 1 BOTTLE (71335-1741-5) 2021-11-300000-00-00NoNoCurrent
71335-1741-671335174106120 TABLET, FILM COATED in 1 BOTTLE (71335-1741-6) 2021-10-050000-00-00NoNoCurrent