FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
69434-005
11-digit product format
694340005
Labeler code
69434
Product ID
69434-005_457bc8b2-1eca-69c2-e063-6294a90a7ba1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rosuvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zhejiang Yongtai Pharmaceutical Co., Ltd.
Application
ANDA212059
Marketing category
ANDA
Marketing start
2025-03-02
Substance
ROSUVASTATIN CALCIUM
Active strength
5 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 CALCIUM5 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69434-005-022025-02-28C16284748780-1d6a99b39-fb86-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
69434-005-032025-02-28C16284748780-1d6a99b39-fb86-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
69434-005-022022-01-28C16284748780-1d6a99b39-fb86-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
69434-005-032022-01-28C16284748780-1d6a99b39-fb86-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69434-005-02Rosuvastatin Calcium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9010
69434-005-03Rosuvastatin Calcium500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69434-005ROSUVASTATIN CALCIUM TABLET, FILM COATED [ZHEJIANG YONGTAI PHARMACEUTICAL CO., LTD.]9Current NDC, Legacy NDC, 2 package rows20250303_40c2900e-4659-49ce-ba4b-5df529b3c53b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN40c2900e-4659-49ce-ba4b-5df529b3c53b10
859751rosuvastatin calcium 20 MG Oral TabletPSN40c2900e-4659-49ce-ba4b-5df529b3c53b10
859419rosuvastatin calcium 40 MG Oral TabletPSN40c2900e-4659-49ce-ba4b-5df529b3c53b10
859424rosuvastatin calcium 5 MG Oral TabletPSN40c2900e-4659-49ce-ba4b-5df529b3c53b10
859747rosuvastatin calcium 10 MG Oral TabletSCD40c2900e-4659-49ce-ba4b-5df529b3c53b10
859751rosuvastatin calcium 20 MG Oral TabletSCD40c2900e-4659-49ce-ba4b-5df529b3c53b10
859419rosuvastatin calcium 40 MG Oral TabletSCD40c2900e-4659-49ce-ba4b-5df529b3c53b10
859424rosuvastatin calcium 5 MG Oral TabletSCD40c2900e-4659-49ce-ba4b-5df529b3c53b10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69434-005-026943400050290 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69434-005-02) 2025-03-020000-00-00NoNoCurrent
69434-005-0369434000503500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69434-005-03) 2025-03-020000-00-00NoNoCurrent