FDA.reportPublic FDA data

Rosuvastatin calcium

Product NDC
50090-6524
11-digit product format
500906524
Labeler code
50090
Product ID
50090-6524_0062ce5a-f58e-4b0c-8ffd-f85fe52ed3e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207752
Marketing category
ANDA
Marketing start
2016-10-31
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
50090-6524-0Rosuvastatin calcium30 in 1 BOTTLETABLET, FILM COATED301
50090-6524-1Rosuvastatin calcium90 in 1 BOTTLETABLET, FILM COATED901
50090-6524-2Rosuvastatin calcium100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6524-0EA - Each50090-6524362b3ab5-9334-4e56-bf2a-ab8c7e76a65e12023-07-06
50090-6524-2EA - Each50090-6524af3471d4-a50d-4c0b-bbb8-09510516bde812023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6524ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM ) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20230616_5f392edb-f7fc-40b4-8446-35494e83a69e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859751rosuvastatin calcium 20 MG Oral TabletPSN5f392edb-f7fc-40b4-8446-35494e83a69e1
859751rosuvastatin calcium 20 MG Oral TabletSCD5f392edb-f7fc-40b4-8446-35494e83a69e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6524-05009065240030 TABLET, FILM COATED in 1 BOTTLE (50090-6524-0) 2023-06-13NoNoCurrent
50090-6524-15009065240190 TABLET, FILM COATED in 1 BOTTLE (50090-6524-1) 2023-06-13NoNoCurrent
50090-6524-250090652402100 TABLET, FILM COATED in 1 BOTTLE (50090-6524-2) 2023-06-13NoNoCurrent