FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
51655-062
11-digit product format
516550062
Labeler code
51655
Product ID
51655-062_499c8f58-2a2c-5430-e063-6294a90a2b6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA208898
Marketing category
ANDA
Marketing start
2022-09-27
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
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 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
51655-062-522026-01-29C16284748780-149896155-a324-586f-e063-e6dba90add90These 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
51655-062-832026-01-29C16284748780-149896155-a324-586f-e063-e6dba90add90These 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
51655-062-52Rosuvastatin Calcium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304
51655-062-83Rosuvastatin Calcium180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-062ROSUVASTATIN CALCIUM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 2 package rows20240709_f2a1008e-963c-9999-e053-2a95a90ae726.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSNf2a1008e-963c-9999-e053-2a95a90ae7264
859747rosuvastatin calcium 10 MG Oral TabletSCDf2a1008e-963c-9999-e053-2a95a90ae7264

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-062-525165500625230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-062-52) 2022-09-27NoNoHistorical
51655-062-8351655006283180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-062-83) 2023-06-06NoNoHistorical