FDA.reportPublic FDA data

ROSUVASTATIN CALCIUM

Product NDC
24658-264
11-digit product format
246580264
Labeler code
24658
Product ID
24658-264_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
40 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 CALCIUM40 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
24658-264-30ROSUVASTATIN CALCIUM30 in 1 BOTTLETABLET302
24658-264-45ROSUVASTATIN CALCIUM45 in 1 BOTTLETABLET452
24658-264-90ROSUVASTATIN CALCIUM90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24658-264-30EA - Each24658-26480dedb7d-427f-4c3a-b6d7-74460a1533e712023-09-05
24658-264-45EA - Each24658-2645d942e41-8e41-4052-a854-6269140db7ed12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24658-264ROSUVASTATIN CALCIUM TABLET [PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS]2Current NDC, 3 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 TabletPSN113160c7-7b41-5395-e063-6394a90a1e152
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 TabletSCD113160c7-7b41-5395-e063-6394a90a1e152
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
24658-264-302465802643030 TABLET in 1 BOTTLE (24658-264-30) 30 tablet2023-08-23NoNoHistorical
24658-264-452465802644545 TABLET in 1 BOTTLE (24658-264-45) 45 tablet2023-08-23NoNoHistorical
24658-264-902465802649090 TABLET in 1 BOTTLE (24658-264-90) 90 tablet2023-08-23NoNoHistorical