FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
71205-820
11-digit product format
712050820
Labeler code
71205
Product ID
71205-820_76bbea68-52d8-4ba9-a772-0ba75a38f2eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA206465
Marketing category
ANDA
Marketing start
2017-03-21
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
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
71205-820-30Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED301
71205-820-60Rosuvastatin Calcium60 in 1 BOTTLETABLET, FILM COATED601
71205-820-90Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-820-30EA - Each71205-8200f061767-adae-48d4-94c9-3588bd7b99ea12023-08-08
71205-820-90EA - Each71205-82029c1735b-7771-4a52-9203-94084f8fb85912023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-820ROSUVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, 3 package rows20230711_76bbea68-52d8-4ba9-a772-0ba75a38f2eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN76bbea68-52d8-4ba9-a772-0ba75a38f2eb1
859747rosuvastatin calcium 10 MG Oral TabletSCD76bbea68-52d8-4ba9-a772-0ba75a38f2eb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-820-307120508203030 TABLET, FILM COATED in 1 BOTTLE (71205-820-30) 2023-07-06NoNoCurrent
71205-820-607120508206060 TABLET, FILM COATED in 1 BOTTLE (71205-820-60) 2023-07-06NoNoCurrent
71205-820-907120508209090 TABLET, FILM COATED in 1 BOTTLE (71205-820-90) 2023-07-06NoNoCurrent