FDA.reportPublic FDA data

ROSUVASTATIN CALCIUM

Product NDC
24658-263
11-digit product format
246580263
Labeler code
24658
Product ID
24658-263_39b848aa-fb65-4b04-916c-1c83589ff3ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROSUVASTATIN CALCIUM
Dosage form
TABLET
Route
ORAL
Labeler
PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
Application
ANDA207752
Marketing category
ANDA
Marketing start
2023-08-23
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
24658-263-45ROSUVASTATIN CALCIUM45 in 1 BOTTLETABLET452
24658-263-90ROSUVASTATIN CALCIUM90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24658-263-45EA - Each24658-2632965ba69-cf8e-4f35-ad10-deba15c55a2612023-09-05
24658-263-90EA - Each24658-263d6921b63-92ec-4bcd-89d3-846b2fd1c9cf12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24658-263ROSUVASTATIN CALCIUM TABLET [PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS]2Current NDC, 2 package rows20250110_9333c674-5714-41ed-8a16-dc7c3e50b9a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN9333c674-5714-41ed-8a16-dc7c3e50b9a42
859751rosuvastatin calcium 20 MG Oral TabletPSN9333c674-5714-41ed-8a16-dc7c3e50b9a42
859419rosuvastatin calcium 40 MG Oral TabletPSN9333c674-5714-41ed-8a16-dc7c3e50b9a42
859424rosuvastatin calcium 5 MG Oral TabletPSN9333c674-5714-41ed-8a16-dc7c3e50b9a42
859747rosuvastatin calcium 10 MG Oral TabletSCD9333c674-5714-41ed-8a16-dc7c3e50b9a42
859751rosuvastatin calcium 20 MG Oral TabletSCD9333c674-5714-41ed-8a16-dc7c3e50b9a42
859419rosuvastatin calcium 40 MG Oral TabletSCD9333c674-5714-41ed-8a16-dc7c3e50b9a42
859424rosuvastatin calcium 5 MG Oral TabletSCD9333c674-5714-41ed-8a16-dc7c3e50b9a42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
24658-263-452465802634545 TABLET in 1 BOTTLE (24658-263-45) 45 tablet2023-08-23NoNoHistorical
24658-263-902465802639090 TABLET in 1 BOTTLE (24658-263-90) 90 tablet2023-08-23NoNoHistorical