FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
63629-7157
11-digit product format
636297157
Labeler code
63629
Product ID
63629-7157_29b451b9-9f2d-4f81-a3b3-ea989802a17e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA079170
Marketing category
ANDA
Marketing start
2016-07-19
Substance
ROSUVASTATIN CALCIUM
Active strength
10 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 CALCIUM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83MVU38M7Q
Rxcui859747

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-7157-12020-10-12C16284748780-19d75b9d0-aed9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
63629-7157-22020-10-12C16284748780-19d75b9d0-aed9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
63629-7157-12020-01-31C16284748780-19d75b9d0-aed9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
63629-7157-22020-01-31C16284748780-19d75b9d0-aed9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7157-1Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED309
63629-7157-2Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED909
63629-7157-3Rosuvastatin Calcium60 in 1 BOTTLETABLET, FILM COATED609
63629-7157-4Rosuvastatin Calcium120 in 1 BOTTLETABLET, FILM COATED1209
63629-7157-5Rosuvastatin Calcium180 in 1 BOTTLETABLET, FILM COATED1809
63629-7157-6Rosuvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED1009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7157ROSUVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 6 package rows20250221_3dd06868-6b71-4ddd-bc9c-57e1cf6656a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN3dd06868-6b71-4ddd-bc9c-57e1cf6656a59
859747rosuvastatin calcium 10 MG Oral TabletSCD3dd06868-6b71-4ddd-bc9c-57e1cf6656a59

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-7157-16362971570130 TABLET, FILM COATED in 1 BOTTLE (63629-7157-1) 2017-10-160000-00-00NoNoCurrent
63629-7157-26362971570290 TABLET, FILM COATED in 1 BOTTLE (63629-7157-2) 2016-12-130000-00-00NoNoCurrent
63629-7157-36362971570360 TABLET, FILM COATED in 1 BOTTLE (63629-7157-3) 2021-11-020000-00-00NoNoCurrent
63629-7157-463629715704120 TABLET, FILM COATED in 1 BOTTLE (63629-7157-4) 2025-01-240000-00-00NoNoCurrent
63629-7157-563629715705180 TABLET, FILM COATED in 1 BOTTLE (63629-7157-5) 2025-01-240000-00-00NoNoCurrent
63629-7157-663629715706100 TABLET, FILM COATED in 1 BOTTLE (63629-7157-6) 2025-01-240000-00-00NoNoCurrent