FDA.reportPublic FDA data

Rosuvastatin

Product NDC
71335-2539
11-digit product format
713352539
Labeler code
71335
Product ID
71335-2539_c6941a72-abca-4e4c-a315-b7d054702720
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206381
Marketing category
ANDA
Marketing start
2019-04-24
Substance
ROSUVASTATIN
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii413KH5ZJ73
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
71335-2539-1Rosuvastatin30 in 1 BOTTLETABLET, FILM COATED301
71335-2539-2Rosuvastatin90 in 1 BOTTLETABLET, FILM COATED901
71335-2539-3Rosuvastatin60 in 1 BOTTLETABLET, FILM COATED601
71335-2539-4Rosuvastatin120 in 1 BOTTLETABLET, FILM COATED1201
71335-2539-5Rosuvastatin180 in 1 BOTTLETABLET, FILM COATED1801
71335-2539-6Rosuvastatin100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2539ROSUVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1Current NDC, 6 package rows20241212_e7955483-fecd-4376-b177-c669f862a3ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSNe7955483-fecd-4376-b177-c669f862a3ac1
859747rosuvastatin calcium 10 MG Oral TabletSCDe7955483-fecd-4376-b177-c669f862a3ac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2539-17133525390130 TABLET, FILM COATED in 1 BOTTLE (71335-2539-1) 2024-12-10NoNoCurrent
71335-2539-27133525390290 TABLET, FILM COATED in 1 BOTTLE (71335-2539-2) 2024-12-10NoNoCurrent
71335-2539-37133525390360 TABLET, FILM COATED in 1 BOTTLE (71335-2539-3) 2024-12-10NoNoCurrent
71335-2539-471335253904120 TABLET, FILM COATED in 1 BOTTLE (71335-2539-4) 2024-12-10NoNoCurrent
71335-2539-571335253905180 TABLET, FILM COATED in 1 BOTTLE (71335-2539-5) 2024-12-10NoNoCurrent
71335-2539-671335253906100 TABLET, FILM COATED in 1 BOTTLE (71335-2539-6) 2024-12-10NoNoCurrent