Rosuvastatin Calcium

Product NDC
71335-1330
11-digit product format
713351330
Labeler code
71335
Product ID
71335-1330_45fb199e-a292-4551-97dc-a76f8717f4de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208898
Marketing category
ANDA
Marketing start
2017-11-22
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1330-1Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED30102
71335-1330-2Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED90102
71335-1330-3Rosuvastatin Calcium28 in 1 BOTTLETABLET, FILM COATED28102
71335-1330-4Rosuvastatin Calcium60 in 1 BOTTLETABLET, FILM COATED60102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1330ROSUVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 4 package rows20240830_199df185-dab0-4de1-95f7-a70e57b9c2b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859424rosuvastatin calcium 5 MG Oral TabletPSN199df185-dab0-4de1-95f7-a70e57b9c2b1102
859424rosuvastatin calcium 5 MG Oral TabletSCD199df185-dab0-4de1-95f7-a70e57b9c2b1102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1330-17133513300130 TABLET, FILM COATED in 1 BOTTLE (71335-1330-1) 2022-02-090000-00-00NoNoCurrent
71335-1330-27133513300290 TABLET, FILM COATED in 1 BOTTLE (71335-1330-2) 2022-02-090000-00-00NoNoCurrent
71335-1330-37133513300328 TABLET, FILM COATED in 1 BOTTLE (71335-1330-3) 2022-02-090000-00-00NoNoCurrent
71335-1330-47133513300460 TABLET, FILM COATED in 1 BOTTLE (71335-1330-4) 2022-02-090000-00-00NoNoCurrent