FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
71335-2055
11-digit product format
713352055
Labeler code
71335
Product ID
71335-2055_5acc5f32-0f8d-441b-b591-4559f612cbb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207408
Marketing category
ANDA
Marketing start
2018-01-08
Substance
ROSUVASTATIN CALCIUM
Active strength
40 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 CALCIUM40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83MVU38M7Q
Rxcui859419

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
71335-2055-1Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED30103
71335-2055-2Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED90103
71335-2055-3Rosuvastatin Calcium28 in 1 BOTTLETABLET, FILM COATED28103
71335-2055-4Rosuvastatin Calcium10 in 1 BOTTLETABLET, FILM COATED10103
71335-2055-5Rosuvastatin Calcium60 in 1 BOTTLETABLET, FILM COATED60103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2055-1EA - Each71335-205588b704fb-4749-4476-9b46-4f22873a3fc012024-08-12
71335-2055-2EA - Each71335-205583bb2da7-e979-4ba9-91aa-1c202a9744b012024-08-12
71335-2055-5EA - Each71335-2055767bbc55-5a5a-4c2a-85dc-5e6ba8b6ed9f12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2055ROSUVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 5 package rows20240830_c277c6fd-f8dd-41d8-8686-38c25d05d192.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859419rosuvastatin calcium 40 MG Oral TabletPSNc277c6fd-f8dd-41d8-8686-38c25d05d192103
859419rosuvastatin calcium 40 MG Oral TabletSCDc277c6fd-f8dd-41d8-8686-38c25d05d192103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2055-17133520550130 TABLET, FILM COATED in 1 BOTTLE (71335-2055-1) 2022-03-140000-00-00NoNoCurrent
71335-2055-27133520550290 TABLET, FILM COATED in 1 BOTTLE (71335-2055-2) 2022-03-140000-00-00NoNoCurrent
71335-2055-37133520550328 TABLET, FILM COATED in 1 BOTTLE (71335-2055-3) 2022-03-140000-00-00NoNoCurrent
71335-2055-47133520550410 TABLET, FILM COATED in 1 BOTTLE (71335-2055-4) 2022-03-140000-00-00NoNoCurrent
71335-2055-57133520550560 TABLET, FILM COATED in 1 BOTTLE (71335-2055-5) 2024-07-10NoNoHistorical