FDA.reportPublic FDA data

ROSUVASTATIN CALCIUM

Product NDC
71205-355
11-digit product format
712050355
Labeler code
71205
Product ID
71205-355_0ddbf155-487b-4b05-b18b-f4d8b40c746e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROSUVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA206434
Marketing category
ANDA
Marketing start
2016-10-31
Substance
ROSUVASTATIN CALCIUM
Active strength
5 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 CALCIUM5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83MVU38M7Q
Rxcui859424

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-355-30ROSUVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED302
71205-355-60ROSUVASTATIN CALCIUM60 in 1 BOTTLETABLET, FILM COATED602
71205-355-90ROSUVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-355-30EA - Each71205-3555ed2d034-e0df-4467-94f2-ba210dad184612020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-355ROSUVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20221111_eaf91ddd-0d4f-4c77-9dba-a2a3abb86ea4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859424rosuvastatin calcium 5 MG Oral TabletPSNeaf91ddd-0d4f-4c77-9dba-a2a3abb86ea42
859424rosuvastatin calcium 5 MG Oral TabletSCDeaf91ddd-0d4f-4c77-9dba-a2a3abb86ea42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-355-307120503553030 TABLET, FILM COATED in 1 BOTTLE (71205-355-30) 2019-11-010000-00-00NoNoCurrent
71205-355-607120503556060 TABLET, FILM COATED in 1 BOTTLE (71205-355-60) 2019-11-010000-00-00NoNoCurrent
71205-355-907120503559090 TABLET, FILM COATED in 1 BOTTLE (71205-355-90) 2019-11-010000-00-00NoNoCurrent