FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
50090-6522
11-digit product format
500906522
Labeler code
50090
Product ID
50090-6522_d28f3d49-51dd-4100-8f27-ef80c96420ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA079170
Marketing category
ANDA
Marketing start
2016-07-19
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
50090-6522-0Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED303
50090-6522-1Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED903
50090-6522-2Rosuvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6522-0EA - Each50090-6522bcf40d56-a6ee-457a-b3cf-5b81a3640db312023-07-06
50090-6522-1EA - Each50090-65222bbb682e-159a-4a03-ad24-076e3769dc3512023-07-06
50090-6522-2EA - Each50090-6522272df36f-4368-45e0-b81c-40f9b3453b9e12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6522ROSUVASTATIN CALCIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Current NDC, 3 package rows20241030_d147d4b2-5c2a-44d2-abb6-e77715f2b0f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859751rosuvastatin calcium 20 MG Oral TabletPSNd147d4b2-5c2a-44d2-abb6-e77715f2b0f53
859751rosuvastatin calcium 20 MG Oral TabletSCDd147d4b2-5c2a-44d2-abb6-e77715f2b0f53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6522-05009065220030 TABLET, FILM COATED in 1 BOTTLE (50090-6522-0) 2023-06-13NoNoCurrent
50090-6522-15009065220190 TABLET, FILM COATED in 1 BOTTLE (50090-6522-1) 2023-06-13NoNoCurrent
50090-6522-250090652202100 TABLET, FILM COATED in 1 BOTTLE (50090-6522-2) 2023-06-13NoNoCurrent