Rosuvastatin Calcium

Product NDC
71205-279
11-digit product format
712050279
Labeler code
71205
Product ID
71205-279_1b45d342-8e4c-4b95-a08f-c910ef65f335
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA079172
Marketing category
ANDA
Marketing start
2016-07-19
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 Calcium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN CALCIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83MVU38M7Q
Rxcui859751

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
71205-279-30Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED303
71205-279-60Rosuvastatin Calcium60 in 1 BOTTLETABLET, FILM COATED603
71205-279-90Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-279-30EA - Each71205-2793889f2c7-4974-4016-a976-6299656b349412019-08-06
71205-279-90EA - Each71205-27914170945-f6bd-43fa-8c5a-d162814d3f6012021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-279ROSUVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20220430_c40d5c38-3585-47ed-ad81-6ad2da91c9c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859751rosuvastatin calcium 20 MG Oral TabletPSNc40d5c38-3585-47ed-ad81-6ad2da91c9c83
859751rosuvastatin calcium 20 MG Oral TabletSCDc40d5c38-3585-47ed-ad81-6ad2da91c9c83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-279-307120502793030 TABLET, FILM COATED in 1 BOTTLE (71205-279-30) 2019-06-010000-00-00NoNoCurrent
71205-279-607120502796060 TABLET, FILM COATED in 1 BOTTLE (71205-279-60) 2019-06-010000-00-00NoNoCurrent
71205-279-907120502799090 TABLET, FILM COATED in 1 BOTTLE (71205-279-90) 2019-06-010000-00-00NoNoCurrent