FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
72603-365
11-digit product format
726030365
Labeler code
72603
Product ID
72603-365_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
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN CALCIUM10 mg/1

Harmonized Identifiers#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-365-01Rosuvastatin Calcium90 in 1 BOTTLETABLET902
72603-365-02Rosuvastatin Calcium1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-365-01EA - Each72603-36532e778be-5bc9-4d75-b056-1222d8025dd712026-03-17
72603-365-02EA - Each72603-365eccb206f-903f-4d1b-95db-f684941b489112026-03-17

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
859747rosuvastatin calcium 10 MG Oral TabletPSN2984f47e-9246-46d0-842e-43c540dd12a51
859747rosuvastatin calcium 10 MG Oral TabletPSN2c72feef-6742-4d8a-9515-89be4e430c4f1
859747rosuvastatin calcium 10 MG Oral TabletSCD2984f47e-9246-46d0-842e-43c540dd12a51
859747rosuvastatin calcium 10 MG Oral TabletSCD2c72feef-6742-4d8a-9515-89be4e430c4f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-365-017260303650190 TABLET in 1 BOTTLE (72603-365-01) 90 tablet2025-12-15NoNoCurrent
72603-365-02726030365021000 TABLET in 1 BOTTLE (72603-365-02) 1000 tablet2025-12-15NoNoCurrent