FDA.reportPublic FDA data

Rosuvastatin

Product NDC
71610-797
11-digit product format
716100797
Labeler code
71610
Product ID
71610-797_1300cf91-1b5b-05dd-e063-6294a90a4b62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA206381
Marketing category
ANDA
Marketing start
2019-04-24
Substance
ROSUVASTATIN
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii413KH5ZJ73
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
71610-797-15Rosuvastatin15 in 1 BOTTLETABLET, FILM COATED153
71610-797-45Rosuvastatin45 in 1 BOTTLETABLET, FILM COATED453

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-797-15EA - Each71610-7972b182d3e-7d8c-48ac-bd7c-0f4884c0206c12024-05-16
71610-797-45EA - Each71610-7978d476227-487a-46f7-ae97-724c1016f5a112024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-797ROSUVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]3Current NDC, 2 package rows20240308_11831846-b3ba-ba0b-e063-6394a90a4cb2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN11831846-b3ba-ba0b-e063-6394a90a4cb23
859747rosuvastatin calcium 10 MG Oral TabletSCD11831846-b3ba-ba0b-e063-6394a90a4cb23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-797-157161007971515 TABLET, FILM COATED in 1 BOTTLE (71610-797-15) 2024-03-06NoNoHistorical
71610-797-457161007974545 TABLET, FILM COATED in 1 BOTTLE (71610-797-45) 2024-02-16NoNoHistorical