FDA.reportPublic FDA data

Rosuvastatin

Product NDC
50090-7482
11-digit product format
500907482
Labeler code
50090
Product ID
50090-7482_749ef0df-0eae-4293-b39f-665fc0c09bb7
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
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii413KH5ZJ73
Rxcui859419

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
50090-7482-0Rosuvastatin30 in 1 BOTTLETABLET, FILM COATED301
50090-7482-1Rosuvastatin90 in 1 BOTTLETABLET, FILM COATED901
50090-7482-2Rosuvastatin100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7482-0EA - Each50090-74829d118b62-f10a-4574-ad55-a95982c33a6912025-02-10
50090-7482-1EA - Each50090-7482cc04eb1f-f189-437f-849b-cde9f38c9aa912025-02-10
50090-7482-2EA - Each50090-7482f469d358-71d1-41aa-b9d9-e7694014930a12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7482ROSUVASTATIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20250101_b7f943f4-35da-4aa7-a4fc-810b914748bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859419rosuvastatin calcium 40 MG Oral TabletPSNb7f943f4-35da-4aa7-a4fc-810b914748bf1
859419rosuvastatin calcium 40 MG Oral TabletSCDb7f943f4-35da-4aa7-a4fc-810b914748bf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7482-05009074820030 TABLET, FILM COATED in 1 BOTTLE (50090-7482-0) 2024-12-20NoNoCurrent
50090-7482-15009074820190 TABLET, FILM COATED in 1 BOTTLE (50090-7482-1) 2024-12-20NoNoCurrent
50090-7482-250090748202100 TABLET, FILM COATED in 1 BOTTLE (50090-7482-2) 2024-12-20NoNoCurrent