FDA.reportPublic FDA data

Rosuvastatin calcium

Product NDC
71205-052
11-digit product format
712050052
Labeler code
71205
Product ID
71205-052_5121b2d8-6afb-4875-9922-1444d6e8a465
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA207752
Marketing category
ANDA
Marketing start
2016-10-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-052-30Rosuvastatin calcium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304
71205-052-60Rosuvastatin calcium60 in 1 BOTTLE, PLASTICTABLET, FILM COATED604
71205-052-90Rosuvastatin calcium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-052-30EA - Each71205-0525ff30aa2-b4ef-4cbe-9719-6dacd0f8448e12018-08-13
71205-052-90EA - Each71205-052020a00b1-001d-40f5-8a3e-bad771fcd21112018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-052ROSUVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20221104_d1bd91fd-03fa-4e6c-80c1-ce58b158d8d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSNd1bd91fd-03fa-4e6c-80c1-ce58b158d8d64
859747rosuvastatin calcium 10 MG Oral TabletSCDd1bd91fd-03fa-4e6c-80c1-ce58b158d8d64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-052-307120500523030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-052-30) 2018-06-010000-00-00NoNoCurrent
71205-052-607120500526060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-052-60) 2018-06-010000-00-00NoNoCurrent
71205-052-907120500529090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-052-90) 2018-06-010000-00-00NoNoCurrent