FDA.reportPublic FDA data

Rosuvastatin

Product NDC
50228-117
11-digit product format
502280117
Labeler code
50228
Product ID
50228-117_2fb0db87-33a8-e6a1-e063-6294a90a5b4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ScieGen Pharmaceuticals, Inc.
Application
ANDA206381
Marketing category
ANDA
Marketing start
2019-04-24
Substance
ROSUVASTATIN
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii413KH5ZJ73
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
50228-117-05Rosuvastatin500 in 1 BOTTLETABLET, FILM COATED5009
50228-117-10Rosuvastatin1000 in 1 BOTTLETABLET, FILM COATED10009
50228-117-30Rosuvastatin30 in 1 BOTTLETABLET, FILM COATED309
50228-117-90Rosuvastatin90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-117-05EA - Each50228-11707b6a8f6-9630-4f7e-851c-96265fd9653d12024-02-14
50228-117-10EA - Each50228-117e63c2841-21e2-40b1-ab22-5c83c81b4bfa12024-02-14
50228-117-90EA - Each50228-11736d928d6-c6cb-4aff-a842-a766068456a612024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-117ROSUVASTATIN TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 4 package rows20250309_ee4933c5-0d97-494d-ac0f-2083e0100836.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSNee4933c5-0d97-494d-ac0f-2083e01008369
859751rosuvastatin calcium 20 MG Oral TabletPSNee4933c5-0d97-494d-ac0f-2083e01008369
859419rosuvastatin calcium 40 MG Oral TabletPSNee4933c5-0d97-494d-ac0f-2083e01008369
859424rosuvastatin calcium 5 MG Oral TabletPSNee4933c5-0d97-494d-ac0f-2083e01008369
859747rosuvastatin calcium 10 MG Oral TabletSCDee4933c5-0d97-494d-ac0f-2083e01008369
859751rosuvastatin calcium 20 MG Oral TabletSCDee4933c5-0d97-494d-ac0f-2083e01008369
859419rosuvastatin calcium 40 MG Oral TabletSCDee4933c5-0d97-494d-ac0f-2083e01008369
859424rosuvastatin calcium 5 MG Oral TabletSCDee4933c5-0d97-494d-ac0f-2083e01008369
859747rosuvastatin calcium 10 MG Oral TabletPSNb8b29392-85fa-417b-bd10-10ab0d07381f5
859747rosuvastatin calcium 10 MG Oral TabletSCDb8b29392-85fa-417b-bd10-10ab0d07381f5
859747rosuvastatin calcium 10 MG Oral TabletPSN3153ba21-6314-4d1c-a8f1-9ae7a99c2a1a4
859747rosuvastatin calcium 10 MG Oral TabletSCD3153ba21-6314-4d1c-a8f1-9ae7a99c2a1a4
859747rosuvastatin calcium 10 MG Oral TabletPSN0f02c184-49f3-8fa6-e063-6394a90a50923
859747rosuvastatin calcium 10 MG Oral TabletPSNadf5df0d-a2e8-4c75-b8fd-15351f4223e93
859751rosuvastatin calcium 20 MG Oral TabletPSN0f02c184-49f3-8fa6-e063-6394a90a50923
859419rosuvastatin calcium 40 MG Oral TabletPSN0f02c184-49f3-8fa6-e063-6394a90a50923
859424rosuvastatin calcium 5 MG Oral TabletPSN0f02c184-49f3-8fa6-e063-6394a90a50923
859747rosuvastatin calcium 10 MG Oral TabletSCDadf5df0d-a2e8-4c75-b8fd-15351f4223e93
859747rosuvastatin calcium 10 MG Oral TabletSCD0f02c184-49f3-8fa6-e063-6394a90a50923
859751rosuvastatin calcium 20 MG Oral TabletSCD0f02c184-49f3-8fa6-e063-6394a90a50923
859419rosuvastatin calcium 40 MG Oral TabletSCD0f02c184-49f3-8fa6-e063-6394a90a50923
859424rosuvastatin calcium 5 MG Oral TabletSCD0f02c184-49f3-8fa6-e063-6394a90a50923
859747rosuvastatin calcium 10 MG Oral TabletPSNd4396def-5692-48ef-b3ab-f0ab2baadf271
859747rosuvastatin calcium 10 MG Oral TabletPSNe7955483-fecd-4376-b177-c669f862a3ac1
859747rosuvastatin calcium 10 MG Oral TabletPSN26d14bab-ee7c-49fe-9fb0-8426a589b5991
859747rosuvastatin calcium 10 MG Oral TabletPSN46173656-d889-ec14-e063-6294a90aae811
859424rosuvastatin calcium 5 MG Oral TabletPSNd4396def-5692-48ef-b3ab-f0ab2baadf271
859747rosuvastatin calcium 10 MG Oral TabletSCDd4396def-5692-48ef-b3ab-f0ab2baadf271
859747rosuvastatin calcium 10 MG Oral TabletSCDe7955483-fecd-4376-b177-c669f862a3ac1
859747rosuvastatin calcium 10 MG Oral TabletSCD46173656-d889-ec14-e063-6294a90aae811
859747rosuvastatin calcium 10 MG Oral TabletSCD26d14bab-ee7c-49fe-9fb0-8426a589b5991
859424rosuvastatin calcium 5 MG Oral TabletSCDd4396def-5692-48ef-b3ab-f0ab2baadf271

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50228-117-0550228011705500 TABLET, FILM COATED in 1 BOTTLE (50228-117-05) 2023-09-07NoNoCurrent
50228-117-10502280117101000 TABLET, FILM COATED in 1 BOTTLE (50228-117-10) 2019-04-240000-00-00NoNoCurrent
50228-117-305022801173030 TABLET, FILM COATED in 1 BOTTLE (50228-117-30) 2019-04-240000-00-00NoNoCurrent
50228-117-905022801179090 TABLET, FILM COATED in 1 BOTTLE (50228-117-90) 2019-04-240000-00-00NoNoCurrent