Rosuvastatin

Product NDC
50090-7730
11-digit product format
500907730
Labeler code
50090
Product ID
50090-7730_1d189003-7bcf-4843-9dbe-89b8061a00a1
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
20 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
ROSUVASTATIN20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii413KH5ZJ73
Rxcui859751

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
50090-7730-0Rosuvastatin30 in 1 BOTTLETABLET, FILM COATED301
50090-7730-1Rosuvastatin90 in 1 BOTTLETABLET, FILM COATED901
50090-7730-2Rosuvastatin100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7730-0EA - Each50090-77309555bf02-fcc7-4ba7-84ef-77463e46103b12025-12-16
50090-7730-1EA - Each50090-7730e079ba74-1e0b-4951-bfcc-ca704daee33a12025-12-16
50090-7730-2EA - Each50090-77307673bb51-aa61-477f-8a74-d92ddbfb5abf12025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859751rosuvastatin calcium 20 MG Oral TabletPSN81910817-f976-4936-ae31-d211083d249b1
859751rosuvastatin calcium 20 MG Oral TabletSCD81910817-f976-4936-ae31-d211083d249b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7730-05009077300030 TABLET, FILM COATED in 1 BOTTLE (50090-7730-0) 2025-10-27NoNoCurrent
50090-7730-15009077300190 TABLET, FILM COATED in 1 BOTTLE (50090-7730-1) 2025-10-27NoNoCurrent
50090-7730-250090773002100 TABLET, FILM COATED in 1 BOTTLE (50090-7730-2) 2025-10-27NoNoCurrent