FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
70518-1819
11-digit product format
705181819
Labeler code
70518
Product ID
70518-1819_4db2337c-a326-0d13-e063-6394a90a9aeb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208898
Marketing category
ANDA
Marketing start
2019-01-24
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rosuvastatin Calcium
Listing expiration
2027-12-31

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1819-0Rosuvastatin Calcium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9014
70518-1819-1Rosuvastatin Calcium45 in 1 BOTTLE, PLASTICTABLET, FILM COATED4514
70518-1819-2Rosuvastatin Calcium30 in 1 BLISTER PACKTABLET, FILM COATED3014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1819ROSUVASTATIN CALCIUM TABLET, FILM COATED [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 3 package rows20250228_11fad602-16c2-4c1f-bdf1-867d95f063ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859751rosuvastatin calcium 20 MG Oral TabletPSN11fad602-16c2-4c1f-bdf1-867d95f063ca14
859751rosuvastatin calcium 20 MG Oral TabletSCD11fad602-16c2-4c1f-bdf1-867d95f063ca14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1819-07051818190090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1819-0) 2019-01-240000-00-00NoNoCurrent
70518-1819-17051818190145 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1819-1) 2020-10-080000-00-00NoNoCurrent
70518-1819-27051818190230 TABLET, FILM COATED in 1 BLISTER PACK (70518-1819-2) 2021-08-120000-00-00NoNoCurrent