Rosuvastatin Calcium

Product NDC
50090-6422
11-digit product format
500906422
Labeler code
50090
Product ID
50090-6422_0c7d9f83-3bf0-47ae-8384-3c453a03b922
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA206465
Marketing category
ANDA
Marketing start
2017-03-21
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6422-0Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED303
50090-6422-1Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED903
50090-6422-2Rosuvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6422-0EA - Each50090-6422104a36b8-16e4-48e4-a2ed-9cb3122a36fe12023-05-05
50090-6422-1EA - Each50090-6422221ea06b-a6ef-42fa-b579-262811ac54df12023-05-05
50090-6422-2EA - Each50090-6422bf5c1de0-e13a-49cf-90eb-98edb8bedce612023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6422ROSUVASTATIN CALCIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Current NDC, 3 package rows20230420_0514e340-54a7-470c-8072-c8113fddf2d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859751rosuvastatin calcium 20 MG Oral TabletPSN0514e340-54a7-470c-8072-c8113fddf2d93
859751rosuvastatin calcium 20 MG Oral TabletSCD0514e340-54a7-470c-8072-c8113fddf2d93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6422-05009064220030 TABLET, FILM COATED in 1 BOTTLE (50090-6422-0) 2023-04-04NoNoHistorical
50090-6422-15009064220190 TABLET, FILM COATED in 1 BOTTLE (50090-6422-1) 2023-04-04NoNoHistorical
50090-6422-250090642202100 TABLET, FILM COATED in 1 BOTTLE (50090-6422-2) 2023-04-18NoNoHistorical