FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
63187-865
11-digit product format
631870865
Labeler code
63187
Product ID
63187-865_c6db2f0a-9e4c-4886-a377-b376f756de9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
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
Rxcui859419, 859424, 859747, 859751

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
63187-865-30Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED305
63187-865-60Rosuvastatin Calcium60 in 1 BOTTLETABLET, FILM COATED605
63187-865-90Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-865-30EA - Each63187-8658b6d05ff-6c15-4375-b4cd-b9c9e82ead1b12017-08-11
63187-865-90EA - Each63187-865c79b793e-d163-4554-a5ff-d3f46d9bd59812017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-865ROSUVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20220616_3066f572-e3db-4bf8-b9ee-bd32d9ed8c13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN3066f572-e3db-4bf8-b9ee-bd32d9ed8c135
859751rosuvastatin calcium 20 MG Oral TabletPSN3066f572-e3db-4bf8-b9ee-bd32d9ed8c135
859419rosuvastatin calcium 40 MG Oral TabletPSN3066f572-e3db-4bf8-b9ee-bd32d9ed8c135
859424rosuvastatin calcium 5 MG Oral TabletPSN3066f572-e3db-4bf8-b9ee-bd32d9ed8c135
859747rosuvastatin calcium 10 MG Oral TabletSCD3066f572-e3db-4bf8-b9ee-bd32d9ed8c135
859751rosuvastatin calcium 20 MG Oral TabletSCD3066f572-e3db-4bf8-b9ee-bd32d9ed8c135
859419rosuvastatin calcium 40 MG Oral TabletSCD3066f572-e3db-4bf8-b9ee-bd32d9ed8c135
859424rosuvastatin calcium 5 MG Oral TabletSCD3066f572-e3db-4bf8-b9ee-bd32d9ed8c135

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-865-306318708653030 TABLET, FILM COATED in 1 BOTTLE (63187-865-30) 2017-06-010000-00-00NoNoCurrent
63187-865-606318708656060 TABLET, FILM COATED in 1 BOTTLE (63187-865-60) 2017-06-010000-00-00NoNoCurrent
63187-865-906318708659090 TABLET, FILM COATED in 1 BOTTLE (63187-865-90) 2017-06-010000-00-00NoNoCurrent