FDA.reportPublic FDA data

Rosuvastatin calcium

Product NDC
71335-1889
11-digit product format
713351889
Labeler code
71335
Product ID
71335-1889_15200cab-6cc5-4bf2-a492-ca94fc25e656
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
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 calcium
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
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
71335-1889-1Rosuvastatin calcium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED30102
71335-1889-2Rosuvastatin calcium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED90102
71335-1889-3Rosuvastatin calcium28 in 1 BOTTLE, PLASTICTABLET, FILM COATED28102
71335-1889-4Rosuvastatin calcium60 in 1 BOTTLE, PLASTICTABLET, FILM COATED60102
71335-1889-5Rosuvastatin calcium100 in 1 BOTTLE, PLASTICTABLET, FILM COATED100102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1889ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM ) TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 5 package rows20231122_e41da8b8-db23-49e1-9ee0-55423d285980.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859424rosuvastatin calcium 5 MG Oral TabletPSNe41da8b8-db23-49e1-9ee0-55423d285980102
859424rosuvastatin calcium 5 MG Oral TabletSCDe41da8b8-db23-49e1-9ee0-55423d285980102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1889-17133518890130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1889-1) 2021-09-020000-00-00NoNoCurrent
71335-1889-27133518890290 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1889-2) 2021-07-300000-00-00NoNoCurrent
71335-1889-37133518890328 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1889-3) 2021-11-040000-00-00NoNoCurrent
71335-1889-47133518890460 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1889-4) 2022-03-100000-00-00NoNoCurrent
71335-1889-571335188905100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1889-5) 2022-03-100000-00-00NoNoCurrent