FDA.reportPublic FDA data

Rosuvastatin calcium

Product NDC
71335-1890
11-digit product format
713351890
Labeler code
71335
Product ID
71335-1890_d662b4b1-af33-4c0a-9499-d9865ae049ee
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
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
71335-1890-1Rosuvastatin calcium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED30103
71335-1890-2Rosuvastatin calcium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED90103
71335-1890-3Rosuvastatin calcium60 in 1 BOTTLE, PLASTICTABLET, FILM COATED60103
71335-1890-4Rosuvastatin calcium120 in 1 BOTTLE, PLASTICTABLET, FILM COATED120103
71335-1890-5Rosuvastatin calcium180 in 1 BOTTLE, PLASTICTABLET, FILM COATED180103
71335-1890-6Rosuvastatin calcium100 in 1 BOTTLE, PLASTICTABLET, FILM COATED100103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1890ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM ) TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 6 package rows20240830_51d0ef20-c80d-44de-ac85-9b73608dba0b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN51d0ef20-c80d-44de-ac85-9b73608dba0b103
859747rosuvastatin calcium 10 MG Oral TabletSCD51d0ef20-c80d-44de-ac85-9b73608dba0b103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1890-17133518900130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1890-1) 2022-02-180000-00-00NoNoCurrent
71335-1890-27133518900290 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1890-2) 2021-07-140000-00-00NoNoCurrent
71335-1890-37133518900360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1890-3) 2022-03-100000-00-00NoNoCurrent
71335-1890-471335189004120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1890-4) 2022-03-100000-00-00NoNoCurrent
71335-1890-571335189005180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1890-5) 2022-03-100000-00-00NoNoCurrent
71335-1890-671335189006100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1890-6) 2022-03-100000-00-00NoNoCurrent