FDA.reportPublic FDA data

Rosuvastatin calcium

Product NDC
50090-5970
11-digit product format
500905970
Labeler code
50090
Product ID
50090-5970_252921c9-9d25-414b-9dc9-40585f49ba83
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
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
50090-5970-0Rosuvastatin calcium30 in 1 BOTTLETABLET, FILM COATED303
50090-5970-1Rosuvastatin calcium90 in 1 BOTTLETABLET, FILM COATED903
50090-5970-2Rosuvastatin calcium100 in 1 BOTTLETABLET, FILM COATED1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5970-0EA - Each50090-5970ed50d6b9-9184-4979-9d00-861162ab8a0312023-10-16
50090-5970-1EA - Each50090-59709283a115-f8df-4e7a-aed7-c1d1d42bc87412023-10-16
50090-5970-2EA - Each50090-59709ea4bc95-2839-4e44-8b13-bdf95459ac5912023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5970ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM ) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 3 package rows20230915_9b8f614f-d49c-464b-b580-5fb9f2c25681.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859419rosuvastatin calcium 40 MG Oral TabletPSN9b8f614f-d49c-464b-b580-5fb9f2c256813
859419rosuvastatin calcium 40 MG Oral TabletSCD9b8f614f-d49c-464b-b580-5fb9f2c256813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5970-05009059700030 TABLET, FILM COATED in 1 BOTTLE (50090-5970-0) 2022-04-280000-00-00NoNoCurrent
50090-5970-15009059700190 TABLET, FILM COATED in 1 BOTTLE (50090-5970-1) 2022-05-040000-00-00NoNoCurrent
50090-5970-250090597002100 TABLET, FILM COATED in 1 BOTTLE (50090-5970-2) 2023-04-20NoNoCurrent