FDA.reportPublic FDA data

Rosuvastatin

Product NDC
51407-851
11-digit product format
514070851
Labeler code
51407
Product ID
51407-851_32d8af6b-ed18-ad03-e063-6394a90a078d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA206381
Marketing category
ANDA
Marketing start
2019-04-24
Substance
ROSUVASTATIN
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii413KH5ZJ73
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
51407-851-10Rosuvastatin1000 in 1 BOTTLETABLET, FILM COATED10003
51407-851-90Rosuvastatin90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-851-10EA - Each51407-8516fa3bf2b-86ab-4721-87e0-c93bd67607d512024-02-14
51407-851-90EA - Each51407-85162dd9400-5985-413e-b4fb-4503a6c7162512024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-851ROSUVASTATIN TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]3Current NDC, 2 package rows20250424_0f02c184-49f3-8fa6-e063-6394a90a5092.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859419rosuvastatin calcium 40 MG Oral TabletPSN1185b112-f59d-8762-e063-6394a90a120d4
859419rosuvastatin calcium 40 MG Oral TabletSCD1185b112-f59d-8762-e063-6394a90a120d4
859747rosuvastatin calcium 10 MG Oral TabletPSN0f02c184-49f3-8fa6-e063-6394a90a50923
859751rosuvastatin calcium 20 MG Oral TabletPSN0f02c184-49f3-8fa6-e063-6394a90a50923
859419rosuvastatin calcium 40 MG Oral TabletPSN0f02c184-49f3-8fa6-e063-6394a90a50923
859424rosuvastatin calcium 5 MG Oral TabletPSN0f02c184-49f3-8fa6-e063-6394a90a50923
859747rosuvastatin calcium 10 MG Oral TabletSCD0f02c184-49f3-8fa6-e063-6394a90a50923
859751rosuvastatin calcium 20 MG Oral TabletSCD0f02c184-49f3-8fa6-e063-6394a90a50923
859419rosuvastatin calcium 40 MG Oral TabletSCD0f02c184-49f3-8fa6-e063-6394a90a50923
859424rosuvastatin calcium 5 MG Oral TabletSCD0f02c184-49f3-8fa6-e063-6394a90a50923

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51407-851-10514070851101000 TABLET, FILM COATED in 1 BOTTLE (51407-851-10) 2023-12-18NoNoCurrent
51407-851-905140708519090 TABLET, FILM COATED in 1 BOTTLE (51407-851-90) 2023-12-18NoNoCurrent