FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
71205-078
11-digit product format
712050078
Labeler code
71205
Product ID
71205-078_300f3b11-59d4-4065-8bfb-e48494bbc407
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA079170
Marketing category
ANDA
Marketing start
2016-07-19
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
71205-078-30Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED305
71205-078-60Rosuvastatin Calcium60 in 1 BOTTLETABLET, FILM COATED605
71205-078-90Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-078-30EA - Each71205-078cad5c1d4-7320-4de8-b7b5-274820ebd78912018-10-11
71205-078-90EA - Each71205-0780a5eb755-096a-49ce-a9d5-238dead9047712020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-078ROSUVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20220811_a9478b12-89d2-42a4-a310-707a87ef43d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859419rosuvastatin calcium 40 MG Oral TabletPSNa9478b12-89d2-42a4-a310-707a87ef43d75
859419rosuvastatin calcium 40 MG Oral TabletSCDa9478b12-89d2-42a4-a310-707a87ef43d75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-078-307120500783030 TABLET, FILM COATED in 1 BOTTLE (71205-078-30) 2018-08-010000-00-00NoNoCurrent
71205-078-607120500786060 TABLET, FILM COATED in 1 BOTTLE (71205-078-60) 2018-08-010000-00-00NoNoCurrent
71205-078-907120500789090 TABLET, FILM COATED in 1 BOTTLE (71205-078-90) 2018-08-010000-00-00NoNoCurrent