FDA.reportPublic FDA data

Rosuvastatin calcium

Product NDC
71205-099
11-digit product format
712050099
Labeler code
71205
Product ID
71205-099_b3e5541d-43f5-46f5-bd98-09f5afbc1499
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA206434
Marketing category
ANDA
Marketing start
2016-10-31
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-099-30Rosuvastatin calcium30 in 1 BOTTLETABLET, FILM COATED305
71205-099-60Rosuvastatin calcium60 in 1 BOTTLETABLET, FILM COATED605
71205-099-90Rosuvastatin calcium90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-099-30EA - Each71205-09967083b1e-7d41-40c9-af7a-643181a810bc12019-09-05
71205-099-90EA - Each71205-099c9a7d081-59d7-4b3a-813e-7847eb044b4f12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-099ROSUVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20221104_aa64d28f-0926-4ff2-bb28-578e5ef233eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859751rosuvastatin calcium 20 MG Oral TabletPSNaa64d28f-0926-4ff2-bb28-578e5ef233eb5
859751rosuvastatin calcium 20 MG Oral TabletSCDaa64d28f-0926-4ff2-bb28-578e5ef233eb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-099-307120500993030 TABLET, FILM COATED in 1 BOTTLE (71205-099-30) 2018-09-040000-00-00NoNoCurrent
71205-099-607120500996060 TABLET, FILM COATED in 1 BOTTLE (71205-099-60) 2018-09-040000-00-00NoNoCurrent
71205-099-907120500999090 TABLET, FILM COATED in 1 BOTTLE (71205-099-90) 2018-09-040000-00-00NoNoCurrent