FDA.reportPublic FDA data

Rosuvastatin

Product NDC
50090-7240
11-digit product format
500907240
Labeler code
50090
Product ID
50090-7240_8e52c7e6-a125-4caf-bb31-892b42f5a361
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
5 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rosuvastatin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii413KH5ZJ73
Rxcui859424

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
50090-7240-0Rosuvastatin30 in 1 BOTTLETABLET, FILM COATED303
50090-7240-1Rosuvastatin90 in 1 BOTTLETABLET, FILM COATED903
50090-7240-2Rosuvastatin100 in 1 BOTTLETABLET, FILM COATED1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7240-0EA - Each50090-7240c9cba752-a4ae-4eec-8f5f-e5b2b62b1bd212024-10-04
50090-7240-1EA - Each50090-72406916670a-102d-46cd-9152-f080f033689f12024-10-04
50090-7240-2EA - Each50090-72409aedbdb7-3d03-400c-acee-ecb0adea5f7912024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7240ROSUVASTATIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20240913_a2ac073e-4d9a-4b0a-8698-a06d73dc6962.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859424rosuvastatin calcium 5 MG Oral TabletPSNa2ac073e-4d9a-4b0a-8698-a06d73dc69623
859424rosuvastatin calcium 5 MG Oral TabletSCDa2ac073e-4d9a-4b0a-8698-a06d73dc69623

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7240-05009072400030 TABLET, FILM COATED in 1 BOTTLE (50090-7240-0) 2024-09-10NoNoHistorical
50090-7240-15009072400190 TABLET, FILM COATED in 1 BOTTLE (50090-7240-1) 2024-09-10NoNoHistorical
50090-7240-250090724002100 TABLET, FILM COATED in 1 BOTTLE (50090-7240-2) 2024-09-10NoNoHistorical