FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
71205-475
11-digit product format
712050475
Labeler code
71205
Product ID
71205-475_b2f702dc-1c6e-4217-b88a-1cc8a54fbb1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA207408
Marketing category
ANDA
Marketing start
2018-01-08
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, 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
71205-475-30Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED302
71205-475-60Rosuvastatin Calcium60 in 1 BOTTLETABLET, FILM COATED602
71205-475-90Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-475-90EA - Each71205-475456cf77d-f5db-46ef-bab7-c5f0675b023012024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-475ROSUVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220602_dcc22d05-cff6-42f9-b9fa-930f2084753f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859751rosuvastatin calcium 20 MG Oral TabletPSNdcc22d05-cff6-42f9-b9fa-930f2084753f2
859419rosuvastatin calcium 40 MG Oral TabletPSNdcc22d05-cff6-42f9-b9fa-930f2084753f2
859751rosuvastatin calcium 20 MG Oral TabletSCDdcc22d05-cff6-42f9-b9fa-930f2084753f2
859419rosuvastatin calcium 40 MG Oral TabletSCDdcc22d05-cff6-42f9-b9fa-930f2084753f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-475-307120504753030 TABLET, FILM COATED in 1 BOTTLE (71205-475-30) 2020-09-220000-00-00NoNoCurrent
71205-475-607120504756060 TABLET, FILM COATED in 1 BOTTLE (71205-475-60) 2020-09-220000-00-00NoNoCurrent
71205-475-907120504759090 TABLET, FILM COATED in 1 BOTTLE (71205-475-90) 2020-09-220000-00-00NoNoCurrent