FDA.reportPublic FDA data

Rosuvastatin calcium

Product NDC
70518-4143
11-digit product format
705184143
Labeler code
70518
Product ID
70518-4143_4cab8619-71f3-7e8e-e063-6294a90a52b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA079172
Marketing category
ANDA
Marketing start
2024-07-17
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rosuvastatin calcium
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4143-0Rosuvastatin calcium30 in 1 BOXTABLET, FILM COATED306
70518-4143-1Rosuvastatin calcium1 in 1 POUCHTABLET, FILM COATED16
70518-4143-2Rosuvastatin calcium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4143ROSUVASTATIN CALCIUM TABLET, FILM COATED [REMEDYREPACK INC.]3Current NDC, 3 package rows20250104_94245f53-2892-4209-8c94-c32c87d5b106.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN94245f53-2892-4209-8c94-c32c87d5b1066
859747rosuvastatin calcium 10 MG Oral TabletSCD94245f53-2892-4209-8c94-c32c87d5b1066

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4143-07051841430030 in 1 BOXHistorical
70518-4143-1705184143011 in 1 POUCHHistorical
70518-4143-27051841430290 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4143-2) 2024-07-29NoNoHistorical