FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
71610-232
11-digit product format
716100232
Labeler code
71610
Product ID
71610-232_e177d76d-1ef4-4218-9e40-07cdf617857b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA207408
Marketing category
ANDA
Marketing start
2016-10-31
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, 859747, 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
71610-232-15Rosuvastatin Calcium15 in 1 BOTTLETABLET, FILM COATED153
71610-232-16Rosuvastatin Calcium6000 in 1 BOTTLETABLET, FILM COATED60003
71610-232-18Rosuvastatin Calcium3000 in 1 BOTTLETABLET, FILM COATED30003
71610-232-42Rosuvastatin Calcium1800 in 1 BOTTLETABLET, FILM COATED18003
71610-232-45Rosuvastatin Calcium45 in 1 BOTTLETABLET, FILM COATED453

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-232-15EA - Each71610-23239f483ae-993c-410f-b47d-5af033635b3612019-03-12
71610-232-16EA - Each71610-232c188b6cc-017b-4de5-80f5-d2a6430f6a5112019-03-12
71610-232-18EA - Each71610-232bad63955-53c3-473b-a649-13bf92301ebb12024-01-04
71610-232-42EA - Each71610-232990ab1ad-19f9-4f0d-839e-0491ad98d4f912024-02-14
71610-232-45EA - Each71610-23263ff44b5-fb68-45c8-83ad-0952fc8c6ace12019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-232ROSUVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Current NDC, Legacy NDC, 5 package rows20230321_ab6c1601-5152-443c-98a0-876660d533e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSNab6c1601-5152-443c-98a0-876660d533e83
859751rosuvastatin calcium 20 MG Oral TabletPSNab6c1601-5152-443c-98a0-876660d533e83
859419rosuvastatin calcium 40 MG Oral TabletPSNab6c1601-5152-443c-98a0-876660d533e83
859747rosuvastatin calcium 10 MG Oral TabletSCDab6c1601-5152-443c-98a0-876660d533e83
859751rosuvastatin calcium 20 MG Oral TabletSCDab6c1601-5152-443c-98a0-876660d533e83
859419rosuvastatin calcium 40 MG Oral TabletSCDab6c1601-5152-443c-98a0-876660d533e83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-232-157161002321515 TABLET, FILM COATED in 1 BOTTLE (71610-232-15) 2019-02-010000-00-00NoNoCurrent
71610-232-16716100232166000 TABLET, FILM COATED in 1 BOTTLE (71610-232-16) 2019-02-080000-00-00NoNoCurrent
71610-232-18716100232183000 TABLET, FILM COATED in 1 BOTTLE (71610-232-18) 2023-03-17NoNoHistorical
71610-232-42716100232421800 TABLET, FILM COATED in 1 BOTTLE (71610-232-42) 2023-02-17NoNoHistorical
71610-232-457161002324545 TABLET, FILM COATED in 1 BOTTLE (71610-232-45) 2019-02-010000-00-00NoNoCurrent