FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
50090-5745
11-digit product format
500905745
Labeler code
50090
Product ID
50090-5745_ca69bbb5-8ee4-4ac4-8236-d70a0ccad699
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA079172
Marketing category
ANDA
Marketing start
2019-06-27
Substance
ROSUVASTATIN CALCIUM
Active strength
10 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 CALCIUM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83MVU38M7Q
Rxcui859747

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5745-02023-02-07C16284748780-1f386c64a-3475-0266-e053-dadaa90a7c1aThese 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
50090-5745-12023-02-07C16284748780-1f386c64a-3475-0266-e053-dadaa90a7c1aThese 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
50090-5745-02023-01-30C16284748780-1f386c64a-3475-0266-e053-dadaa90a7c1aThese 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
50090-5745-12023-01-30C16284748780-1f386c64a-3475-0266-e053-dadaa90a7c1aThese 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
50090-5745-0Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED305
50090-5745-1Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED905
50090-5745-2Rosuvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5745-0EA - Each50090-57457c76b057-9add-4b3e-aa88-97746a7bc00a12022-08-04
50090-5745-1EA - Each50090-574542ef9836-7c3b-4fb8-adb0-d988019b8b2912022-08-04
50090-5745-2EA - Each50090-57455133c373-a901-462b-b575-3fe7d5d6fc4d12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5745ROSUVASTATIN CALCIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 3 package rows20240824_3b556f65-fae9-436f-9cc5-3160d1c9b18a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN3b556f65-fae9-436f-9cc5-3160d1c9b18a5
859747rosuvastatin calcium 10 MG Oral TabletSCD3b556f65-fae9-436f-9cc5-3160d1c9b18a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5745-05009057450030 TABLET, FILM COATED in 1 BOTTLE (50090-5745-0) 2021-09-290000-00-00NoNoCurrent
50090-5745-15009057450190 TABLET, FILM COATED in 1 BOTTLE (50090-5745-1) 2021-09-290000-00-00NoNoCurrent
50090-5745-250090574502100 TABLET, FILM COATED in 1 BOTTLE (50090-5745-2) 2024-08-02NoNoCurrent