FDA.reportPublic FDA data

ROSUVASTATIN

Product NDC
72189-065
11-digit product format
721890065
Labeler code
72189
Product ID
72189-065_4c499576-6f7a-6e58-e063-6294a90ab6a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROSUVASTATIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA208898
Marketing category
ANDA
Marketing start
2019-12-10
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN CALCIUM5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83MVU38M7Q
Rxcui859419, 859424

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
72189-065-30ROSUVASTATIN30 in 1 BOTTLETABLET, FILM COATED307
72189-065-90ROSUVASTATIN90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-065-30EA - Each72189-06579f3a205-ed94-4075-9fa4-9102af54ded712020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-065ROSUVASTATIN TABLET, FILM COATED ROSUVASTATIN CALCIUM TABLET, FILM COATED [DIRECT RX]6Current NDC, Legacy NDC, 2 package rows20250119_99602058-4681-7cb5-e053-2995a90a099c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859419rosuvastatin calcium 40 MG Oral TabletPSN99602058-4681-7cb5-e053-2995a90a099c7
859424rosuvastatin calcium 5 MG Oral TabletPSN99602058-4681-7cb5-e053-2995a90a099c7
859419rosuvastatin calcium 40 MG Oral TabletSCD99602058-4681-7cb5-e053-2995a90a099c7
859424rosuvastatin calcium 5 MG Oral TabletSCD99602058-4681-7cb5-e053-2995a90a099c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-065-307218900653030 TABLET, FILM COATED in 1 BOTTLE (72189-065-30) 2019-12-100000-00-00NoNoCurrent
72189-065-907218900659090 TABLET, FILM COATED in 1 BOTTLE (72189-065-90) 2019-12-10NoNoHistorical