FDA.reportPublic FDA data

Rosuvastatin

Product NDC
71335-2406
11-digit product format
713352406
Labeler code
71335
Product ID
71335-2406_8594a4d6-24ef-4baa-a92b-be7c0ac7f7df
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
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii413KH5ZJ73
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
71335-2406-1Rosuvastatin30 in 1 BOTTLETABLET, FILM COATED302
71335-2406-2Rosuvastatin90 in 1 BOTTLETABLET, FILM COATED902
71335-2406-3Rosuvastatin28 in 1 BOTTLETABLET, FILM COATED282
71335-2406-4Rosuvastatin60 in 1 BOTTLETABLET, FILM COATED602
71335-2406-5Rosuvastatin180 in 1 BOTTLETABLET, FILM COATED1802
71335-2406-6Rosuvastatin120 in 1 BOTTLETABLET, FILM COATED1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2406ROSUVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]2Current NDC, 6 package rows20241122_cc9c9664-2601-4dff-843b-1e96f6c8a70a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859751rosuvastatin calcium 20 MG Oral TabletPSNcc9c9664-2601-4dff-843b-1e96f6c8a70a2
859751rosuvastatin calcium 20 MG Oral TabletSCDcc9c9664-2601-4dff-843b-1e96f6c8a70a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2406-17133524060130 TABLET, FILM COATED in 1 BOTTLE (71335-2406-1) 2024-06-14NoNoCurrent
71335-2406-27133524060290 TABLET, FILM COATED in 1 BOTTLE (71335-2406-2) 2024-06-21NoNoCurrent
71335-2406-37133524060328 TABLET, FILM COATED in 1 BOTTLE (71335-2406-3) 2024-11-01NoNoCurrent
71335-2406-47133524060460 TABLET, FILM COATED in 1 BOTTLE (71335-2406-4) 2024-11-01NoNoCurrent
71335-2406-571335240605180 TABLET, FILM COATED in 1 BOTTLE (71335-2406-5) 2024-11-01NoNoCurrent
71335-2406-671335240606120 TABLET, FILM COATED in 1 BOTTLE (71335-2406-6) 2024-11-01NoNoCurrent