FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
50090-6519
11-digit product format
500906519
Labeler code
50090
Product ID
50090-6519_9c392f80-c595-42e9-a077-3a3c97aaf326
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
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 Calcium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN CALCIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83MVU38M7Q
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
50090-6519-0Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED304
50090-6519-1Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED904
50090-6519-2Rosuvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6519-0EA - Each50090-6519ba1d087b-29c3-4658-a7a7-bac0c8a1ec9b12023-07-06
50090-6519-1EA - Each50090-6519e54fbd46-281b-443e-b36c-bc0638849ba012023-07-06
50090-6519-2EA - Each50090-6519cf779243-8fab-4a4f-bb64-0972b7163e4f12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6519ROSUVASTATIN CALCIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]4Current NDC, 3 package rows20230616_e24da1b9-e51d-489a-85f4-43227c210477.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859751rosuvastatin calcium 20 MG Oral TabletPSNe24da1b9-e51d-489a-85f4-43227c2104774
859751rosuvastatin calcium 20 MG Oral TabletSCDe24da1b9-e51d-489a-85f4-43227c2104774

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6519-05009065190030 TABLET, FILM COATED in 1 BOTTLE (50090-6519-0) 2023-06-09NoNoHistorical
50090-6519-15009065190190 TABLET, FILM COATED in 1 BOTTLE (50090-6519-1) 2023-06-09NoNoHistorical
50090-6519-250090651902100 TABLET, FILM COATED in 1 BOTTLE (50090-6519-2) 2023-06-09NoNoHistorical