FDA.reportPublic FDA data

Rosuvastatin

Product NDC
50268-710
11-digit product format
502680710
Labeler code
50268
Product ID
50268-710_39ff0f38-7c7a-4ce1-e063-6394a90aa663
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA207616
Marketing category
ANDA
Marketing start
2018-12-14
Substance
ROSUVASTATIN CALCIUM
Active strength
20 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
ROSUVASTATIN CALCIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83MVU38M7Q
Rxcui859419, 859747, 859751

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
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
50268-710-11Rosuvastatin1 in 1 BLISTER PACKTABLET, FILM COATED14
50268-710-15Rosuvastatin50 in 1 BOXTABLET, FILM COATED504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-710-11EA - Each50268-71062bb98fc-903a-433c-962a-4b2f1ce93c5912019-04-11
50268-710-15EA - Each50268-71065ab382f-7703-4a66-abe9-f558efba336012019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-710ROSUVASTATIN TABLET, FILM COATED [AVPAK]3Current NDC, Legacy NDC, 2 package rows20240110_7cd6ae8d-aa67-60db-e053-2991aa0a0ede.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN0f7fad2c-fc46-4ebc-b55b-6534da99e0534
859747rosuvastatin calcium 10 MG Oral TabletPSN7cd6ae8d-aa67-60db-e053-2991aa0a0ede4
859751rosuvastatin calcium 20 MG Oral TabletPSN0f7fad2c-fc46-4ebc-b55b-6534da99e0534
859751rosuvastatin calcium 20 MG Oral TabletPSN7cd6ae8d-aa67-60db-e053-2991aa0a0ede4
859419rosuvastatin calcium 40 MG Oral TabletPSN7cd6ae8d-aa67-60db-e053-2991aa0a0ede4
859747rosuvastatin calcium 10 MG Oral TabletSCD0f7fad2c-fc46-4ebc-b55b-6534da99e0534
859747rosuvastatin calcium 10 MG Oral TabletSCD7cd6ae8d-aa67-60db-e053-2991aa0a0ede4
859751rosuvastatin calcium 20 MG Oral TabletSCD0f7fad2c-fc46-4ebc-b55b-6534da99e0534
859751rosuvastatin calcium 20 MG Oral TabletSCD7cd6ae8d-aa67-60db-e053-2991aa0a0ede4
859419rosuvastatin calcium 40 MG Oral TabletSCD7cd6ae8d-aa67-60db-e053-2991aa0a0ede4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-710-11502680710111 in 1 BLISTER PACKHistorical
50268-710-155026807101550 BLISTER PACK in 1 BOX (50268-710-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-710-11) 50 blister pack2018-12-140000-00-00NoNoCurrent