FDA.reportPublic FDA data

Rosuvastatin

Product NDC
71335-0749
11-digit product format
713350749
Labeler code
71335
Product ID
71335-0749_c60bc37b-8392-4a9f-8664-83056d2fae58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206434
Marketing category
ANDA
Marketing start
2016-10-31
Substance
ROSUVASTATIN CALCIUM
Active strength
5 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
ROSUVASTATIN CALCIUM5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83MVU38M7Q
Rxcui859424

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0749-1Rosuvastatin30 in 1 BOTTLETABLET, FILM COATED30103
71335-0749-2Rosuvastatin90 in 1 BOTTLETABLET, FILM COATED90103
71335-0749-3Rosuvastatin28 in 1 BOTTLETABLET, FILM COATED28103
71335-0749-4Rosuvastatin60 in 1 BOTTLETABLET, FILM COATED60103
71335-0749-5Rosuvastatin100 in 1 BOTTLETABLET, FILM COATED100103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0749-1EA - Each71335-074941c2086c-7b66-493c-a465-a260e9e58c2912018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0749ROSUVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 5 package rows20241109_0ad5b7de-e97d-4989-91e4-edae73543896.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859424rosuvastatin calcium 5 MG Oral TabletPSN0ad5b7de-e97d-4989-91e4-edae73543896103
859424rosuvastatin calcium 5 MG Oral TabletSCD0ad5b7de-e97d-4989-91e4-edae73543896103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0749-17133507490130 TABLET, FILM COATED in 1 BOTTLE (71335-0749-1) 2018-04-130000-00-00NoNoCurrent
71335-0749-27133507490290 TABLET, FILM COATED in 1 BOTTLE (71335-0749-2) 2018-03-210000-00-00NoNoCurrent
71335-0749-37133507490328 TABLET, FILM COATED in 1 BOTTLE (71335-0749-3) 2021-12-090000-00-00NoNoCurrent
71335-0749-47133507490460 TABLET, FILM COATED in 1 BOTTLE (71335-0749-4) 2024-10-300000-00-00NoNoCurrent
71335-0749-571335074905100 TABLET, FILM COATED in 1 BOTTLE (71335-0749-5) 2024-10-30NoNoHistorical