FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
71335-2035
11-digit product format
713352035
Labeler code
71335
Product ID
71335-2035_59fefd25-8bb1-4775-bb93-f6357ad3c53e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206465
Marketing category
ANDA
Marketing start
2017-03-21
Substance
ROSUVASTATIN CALCIUM
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 Calcium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN CALCIUM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83MVU38M7Q
Rxcui859747

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
71335-2035-1Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED30104
71335-2035-2Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED90104
71335-2035-3Rosuvastatin Calcium60 in 1 BOTTLETABLET, FILM COATED60104
71335-2035-4Rosuvastatin Calcium120 in 1 BOTTLETABLET, FILM COATED120104
71335-2035-5Rosuvastatin Calcium180 in 1 BOTTLETABLET, FILM COATED180104
71335-2035-6Rosuvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED100104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2035ROSUVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 6 package rows20240423_67da041b-7ad5-4309-86b3-8c30a5f9465e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN67da041b-7ad5-4309-86b3-8c30a5f9465e104
859747rosuvastatin calcium 10 MG Oral TabletSCD67da041b-7ad5-4309-86b3-8c30a5f9465e104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2035-17133520350130 TABLET, FILM COATED in 1 BOTTLE (71335-2035-1) 2024-04-030000-00-00NoNoCurrent
71335-2035-27133520350290 TABLET, FILM COATED in 1 BOTTLE (71335-2035-2) 2024-04-030000-00-00NoNoCurrent
71335-2035-37133520350360 TABLET, FILM COATED in 1 BOTTLE (71335-2035-3) 2024-04-030000-00-00NoNoCurrent
71335-2035-471335203504120 TABLET, FILM COATED in 1 BOTTLE (71335-2035-4) 2022-06-230000-00-00NoNoCurrent
71335-2035-571335203505180 TABLET, FILM COATED in 1 BOTTLE (71335-2035-5) 2022-02-020000-00-00NoNoCurrent
71335-2035-671335203506100 TABLET, FILM COATED in 1 BOTTLE (71335-2035-6) 2024-04-03NoNoCurrent