FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
51407-156
11-digit product format
514070156
Labeler code
51407
Product ID
51407-156_31d1bb38-738d-23fa-e063-6294a90ae0ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA207408
Marketing category
ANDA
Marketing start
2016-10-31
Marketing end
2026-07-31
Substance
ROSUVASTATIN CALCIUM
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rosuvastatin Calcium

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN CALCIUM40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83MVU38M7Q
Rxcui859419, 859424, 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
51407-156-30Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-156-30EA - Each51407-15687261d74-725c-4ae2-bed0-bda4cec4a52d12019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-156ROSUVASTATIN CALCIUM TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]10Current NDC, Legacy NDC, 1 package rows20250406_7c3af5aa-2223-463a-e053-2a91aa0a16f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN7c3af5aa-2223-463a-e053-2a91aa0a16f910
859751rosuvastatin calcium 20 MG Oral TabletPSN7c3af5aa-2223-463a-e053-2a91aa0a16f910
859419rosuvastatin calcium 40 MG Oral TabletPSN7c3af5aa-2223-463a-e053-2a91aa0a16f910
859424rosuvastatin calcium 5 MG Oral TabletPSN7c3af5aa-2223-463a-e053-2a91aa0a16f910
859747rosuvastatin calcium 10 MG Oral TabletSCD7c3af5aa-2223-463a-e053-2a91aa0a16f910
859751rosuvastatin calcium 20 MG Oral TabletSCD7c3af5aa-2223-463a-e053-2a91aa0a16f910
859419rosuvastatin calcium 40 MG Oral TabletSCD7c3af5aa-2223-463a-e053-2a91aa0a16f910
859424rosuvastatin calcium 5 MG Oral TabletSCD7c3af5aa-2223-463a-e053-2a91aa0a16f910
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
51407-156-305140701563030 TABLET, FILM COATED in 1 BOTTLE (51407-156-30) 2018-11-132026-07-31NoNoCurrent