FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
60687-256
11-digit product format
606870256
Labeler code
60687
Product ID
60687-256_401aadf4-8665-4427-e063-6394a90a7820
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA079170
Marketing category
ANDA
Marketing start
2016-09-21
Substance
ROSUVASTATIN CALCIUM
Active strength
20 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 CALCIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83MVU38M7Q
Rxcui859424, 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
60687-256-01Rosuvastatin Calcium100 in 1 BOX, UNIT-DOSETABLET, FILM COATED10011
60687-256-11Rosuvastatin Calcium1 in 1 BLISTER PACKTABLET, FILM COATED111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-256-01EA - Each60687-256a73028c9-7afe-4712-a418-7e2d3bb74b0612016-10-06
60687-256-11EA - Each60687-25610d881ef-c724-4f27-bfba-73c638ce745512016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-256ROSUVASTATIN CALCIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]10Current NDC, Legacy NDC, 2 package rows20241218_b7491a1a-570e-40ea-b65b-f956c9e284a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSNb7491a1a-570e-40ea-b65b-f956c9e284a611
859751rosuvastatin calcium 20 MG Oral TabletPSNb7491a1a-570e-40ea-b65b-f956c9e284a611
859424rosuvastatin calcium 5 MG Oral TabletPSNb7491a1a-570e-40ea-b65b-f956c9e284a611
859747rosuvastatin calcium 10 MG Oral TabletSCDb7491a1a-570e-40ea-b65b-f956c9e284a611
859751rosuvastatin calcium 20 MG Oral TabletSCDb7491a1a-570e-40ea-b65b-f956c9e284a611
859424rosuvastatin calcium 5 MG Oral TabletSCDb7491a1a-570e-40ea-b65b-f956c9e284a611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-256-0160687025601100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-256-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-256-11) 100 blister pack2016-09-210000-00-00NoNoCurrent
60687-256-11606870256111 in 1 BLISTER PACKHistorical