FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
50090-6611
11-digit product format
500906611
Labeler code
50090
Product ID
50090-6611_5300c470-b015-4d5d-9da1-27ea95451bba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208898
Marketing category
ANDA
Marketing start
2017-11-22
Substance
ROSUVASTATIN CALCIUM
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 Calcium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN CALCIUM40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83MVU38M7Q
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
50090-6611-0Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED305
50090-6611-1Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED905
50090-6611-2Rosuvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6611-0EA - Each50090-661113651312-e94f-44ed-b369-b52168a6ca9812023-10-16
50090-6611-1EA - Each50090-6611d5ca4ea5-164c-4430-8d26-d48af625184d12023-10-16
50090-6611-2EA - Each50090-66119bf0e759-fbb1-45d9-8b7e-7e3ea95f147912023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6611ROSUVASTATIN CALCIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Current NDC, 3 package rows20230901_8046d4fa-bd89-49f7-8204-9eb49b648748.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859419rosuvastatin calcium 40 MG Oral TabletPSN8046d4fa-bd89-49f7-8204-9eb49b6487485
859419rosuvastatin calcium 40 MG Oral TabletSCD8046d4fa-bd89-49f7-8204-9eb49b6487485

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6611-05009066110030 TABLET, FILM COATED in 1 BOTTLE (50090-6611-0) 2023-08-24NoNoCurrent
50090-6611-15009066110190 TABLET, FILM COATED in 1 BOTTLE (50090-6611-1) 2023-08-24NoNoCurrent
50090-6611-250090661102100 TABLET, FILM COATED in 1 BOTTLE (50090-6611-2) 2023-08-24NoNoCurrent