FDA.reportPublic FDA data

Rosuvastatin

Product NDC
50090-7430
11-digit product format
500907430
Labeler code
50090
Product ID
50090-7430_ad21cea7-9e75-42d0-93a7-c6cf7f4564b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
Rxcui859747

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
50090-7430-0Rosuvastatin30 in 1 BOTTLETABLET, FILM COATED304
50090-7430-1Rosuvastatin90 in 1 BOTTLETABLET, FILM COATED904
50090-7430-2Rosuvastatin100 in 1 BOTTLETABLET, FILM COATED1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7430-0EA - Each50090-74305e467c96-3217-47b0-afa3-7d6b428ba20a12024-12-10
50090-7430-1EA - Each50090-7430087bcb73-6587-478e-ab16-0346e3e215e912024-12-10
50090-7430-2EA - Each50090-7430d7ec5063-41d9-4956-a7e4-07ffb2e1fb4a12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7430ROSUVASTATIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20241105_3153ba21-6314-4d1c-a8f1-9ae7a99c2a1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN3153ba21-6314-4d1c-a8f1-9ae7a99c2a1a4
859747rosuvastatin calcium 10 MG Oral TabletSCD3153ba21-6314-4d1c-a8f1-9ae7a99c2a1a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7430-05009074300030 TABLET, FILM COATED in 1 BOTTLE (50090-7430-0) 2024-11-01NoNoCurrent
50090-7430-15009074300190 TABLET, FILM COATED in 1 BOTTLE (50090-7430-1) 2024-11-01NoNoCurrent
50090-7430-250090743002100 TABLET, FILM COATED in 1 BOTTLE (50090-7430-2) 2024-11-01NoNoCurrent