FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
57237-168
11-digit product format
572370168
Labeler code
57237
Product ID
57237-168_20865c19-8939-458b-b3db-d38f3fb00bed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA079170
Marketing category
ANDA
Marketing start
2016-07-19
Substance
ROSUVASTATIN CALCIUM
Active strength
5 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 CALCIUM5 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
57237-168-05Rosuvastatin Calcium500 in 1 BOTTLETABLET, FILM COATED50015
57237-168-30Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED3015
57237-168-90Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED9015
57237-168-99Rosuvastatin Calcium1000 in 1 BOTTLETABLET, FILM COATED100015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-168-05EA - Each57237-168a7f2d6ef-08fb-4e42-8d32-486868c57e8312016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-168ROSUVASTATIN CALCIUM TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]15Current NDC, Legacy NDC, 4 package rows20241219_5c992d3d-d754-48b6-a267-1451208352ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN85ed9283-4e16-41bf-95ed-01b62640fd2c37
859751rosuvastatin calcium 20 MG Oral TabletPSN85ed9283-4e16-41bf-95ed-01b62640fd2c37
859419rosuvastatin calcium 40 MG Oral TabletPSN85ed9283-4e16-41bf-95ed-01b62640fd2c37
859424rosuvastatin calcium 5 MG Oral TabletPSN85ed9283-4e16-41bf-95ed-01b62640fd2c37
859747rosuvastatin calcium 10 MG Oral TabletSCD85ed9283-4e16-41bf-95ed-01b62640fd2c37
859751rosuvastatin calcium 20 MG Oral TabletSCD85ed9283-4e16-41bf-95ed-01b62640fd2c37
859419rosuvastatin calcium 40 MG Oral TabletSCD85ed9283-4e16-41bf-95ed-01b62640fd2c37
859424rosuvastatin calcium 5 MG Oral TabletSCD85ed9283-4e16-41bf-95ed-01b62640fd2c37
859747rosuvastatin calcium 10 MG Oral TabletPSN5c992d3d-d754-48b6-a267-1451208352ed15
859751rosuvastatin calcium 20 MG Oral TabletPSN5c992d3d-d754-48b6-a267-1451208352ed15
859419rosuvastatin calcium 40 MG Oral TabletPSN5c992d3d-d754-48b6-a267-1451208352ed15
859424rosuvastatin calcium 5 MG Oral TabletPSN5c992d3d-d754-48b6-a267-1451208352ed15
859747rosuvastatin calcium 10 MG Oral TabletSCD5c992d3d-d754-48b6-a267-1451208352ed15
859751rosuvastatin calcium 20 MG Oral TabletSCD5c992d3d-d754-48b6-a267-1451208352ed15
859419rosuvastatin calcium 40 MG Oral TabletSCD5c992d3d-d754-48b6-a267-1451208352ed15
859424rosuvastatin calcium 5 MG Oral TabletSCD5c992d3d-d754-48b6-a267-1451208352ed15
859747rosuvastatin calcium 10 MG Oral TabletPSNb7491a1a-570e-40ea-b65b-f956c9e284a611
859751rosuvastatin calcium 20 MG Oral TabletPSNb7491a1a-570e-40ea-b65b-f956c9e284a611
859424rosuvastatin calcium 5 MG Oral TabletPSNb7491a1a-570e-40ea-b65b-f956c9e284a611
859747rosuvastatin calcium 10 MG Oral TabletSCDb7491a1a-570e-40ea-b65b-f956c9e284a611
859751rosuvastatin calcium 20 MG Oral TabletSCDb7491a1a-570e-40ea-b65b-f956c9e284a611
859424rosuvastatin calcium 5 MG Oral TabletSCDb7491a1a-570e-40ea-b65b-f956c9e284a611
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
859747rosuvastatin calcium 10 MG Oral TabletPSN77fd8268-f623-4ba1-b8f3-652f743a40191
859751rosuvastatin calcium 20 MG Oral TabletPSN77fd8268-f623-4ba1-b8f3-652f743a40191
859424rosuvastatin calcium 5 MG Oral TabletPSN77fd8268-f623-4ba1-b8f3-652f743a40191
859747rosuvastatin calcium 10 MG Oral TabletSCD77fd8268-f623-4ba1-b8f3-652f743a40191
859751rosuvastatin calcium 20 MG Oral TabletSCD77fd8268-f623-4ba1-b8f3-652f743a40191
859424rosuvastatin calcium 5 MG Oral TabletSCD77fd8268-f623-4ba1-b8f3-652f743a40191

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57237-168-0557237016805500 TABLET, FILM COATED in 1 BOTTLE (57237-168-05) 2016-07-190000-00-00NoNoCurrent
57237-168-305723701683030 TABLET, FILM COATED in 1 BOTTLE (57237-168-30) 2016-07-190000-00-00NoNoCurrent
57237-168-905723701689090 TABLET, FILM COATED in 1 BOTTLE (57237-168-90) 2016-07-190000-00-00NoNoCurrent
57237-168-99572370168991000 TABLET, FILM COATED in 1 BOTTLE (57237-168-99) 2016-07-190000-00-00NoNoCurrent