FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
72603-367
11-digit product format
726030367
Labeler code
72603
Product ID
72603-367_4687569b-7762-fb06-e063-6294a90aadc7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
NorthStar Rx, LLC
Application
ANDA207626
Marketing category
ANDA
Marketing start
2025-12-15
Substance
ROSUVASTATIN CALCIUM
Active strength
40 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 CALCIUM40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83MVU38M7Q
Rxcui859419, 859424, 859747, 859751

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
72603-367-01Rosuvastatin Calcium30 in 1 BOTTLETABLET302
72603-367-02Rosuvastatin Calcium90 in 1 BOTTLETABLET902
72603-367-03Rosuvastatin Calcium500 in 1 BOTTLETABLET5002
72603-367-04Rosuvastatin Calcium1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-367-01EA - Each72603-367f0974458-0829-4037-ab40-7eda95f43c9a12026-03-17
72603-367-02EA - Each72603-3670f1d7a8e-6bdf-4e5d-bf37-9c6427e6318012026-03-17
72603-367-03EA - Each72603-36785893b98-b015-424c-a0c5-47f53ee5e8f512026-03-17
72603-367-04EA - Each72603-367cb8f78a2-4136-41ec-92ee-dc87ef7a51dc12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSNc622757d-7370-438b-8c2d-ef444a4f31dd2
859751rosuvastatin calcium 20 MG Oral TabletPSNc622757d-7370-438b-8c2d-ef444a4f31dd2
859419rosuvastatin calcium 40 MG Oral TabletPSNc622757d-7370-438b-8c2d-ef444a4f31dd2
859424rosuvastatin calcium 5 MG Oral TabletPSNc622757d-7370-438b-8c2d-ef444a4f31dd2
859747rosuvastatin calcium 10 MG Oral TabletSCDc622757d-7370-438b-8c2d-ef444a4f31dd2
859751rosuvastatin calcium 20 MG Oral TabletSCDc622757d-7370-438b-8c2d-ef444a4f31dd2
859419rosuvastatin calcium 40 MG Oral TabletSCDc622757d-7370-438b-8c2d-ef444a4f31dd2
859424rosuvastatin calcium 5 MG Oral TabletSCDc622757d-7370-438b-8c2d-ef444a4f31dd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-367-017260303670130 TABLET in 1 BOTTLE (72603-367-01) 30 tablet2025-12-15NoNoCurrent
72603-367-027260303670290 TABLET in 1 BOTTLE (72603-367-02) 90 tablet2025-12-15NoNoCurrent
72603-367-0372603036703500 TABLET in 1 BOTTLE (72603-367-03) 500 tablet2025-12-15NoNoCurrent
72603-367-04726030367041000 TABLET in 1 BOTTLE (72603-367-04) 1000 tablet2025-12-15NoNoCurrent