Rosuvastatin Calcium

Product NDC
71335-1733
11-digit product format
713351733
Labeler code
71335
Product ID
71335-1733_d23071db-2fab-465a-8271-836f70b2f5f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208898
Marketing category
ANDA
Marketing start
2017-11-22
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
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
71335-1733-1Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED30102
71335-1733-2Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED90102
71335-1733-3Rosuvastatin Calcium60 in 1 BOTTLETABLET, FILM COATED60102
71335-1733-4Rosuvastatin Calcium120 in 1 BOTTLETABLET, FILM COATED120102
71335-1733-5Rosuvastatin Calcium180 in 1 BOTTLETABLET, FILM COATED180102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1733ROSUVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 5 package rows20231122_adcbfc8c-e4a7-4576-9f0a-42c59c6e2ad1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSNadcbfc8c-e4a7-4576-9f0a-42c59c6e2ad1102
859747rosuvastatin calcium 10 MG Oral TabletSCDadcbfc8c-e4a7-4576-9f0a-42c59c6e2ad1102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1733-17133517330130 TABLET, FILM COATED in 1 BOTTLE (71335-1733-1) 2021-01-050000-00-00NoNoCurrent
71335-1733-27133517330290 TABLET, FILM COATED in 1 BOTTLE (71335-1733-2) 2021-01-070000-00-00NoNoCurrent
71335-1733-37133517330360 TABLET, FILM COATED in 1 BOTTLE (71335-1733-3) 2021-03-040000-00-00NoNoCurrent
71335-1733-471335173304120 TABLET, FILM COATED in 1 BOTTLE (71335-1733-4) 2021-12-290000-00-00NoNoCurrent
71335-1733-571335173305180 TABLET, FILM COATED in 1 BOTTLE (71335-1733-5) 2021-12-290000-00-00NoNoCurrent