FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
50090-7004
11-digit product format
500907004
Labeler code
50090
Product ID
50090-7004_ce0c3408-3dd8-461c-b570-7d892b888600
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA079172
Marketing category
ANDA
Marketing start
2019-06-27
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
50090-7004-0Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED307
50090-7004-1Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED907
50090-7004-2Rosuvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7004-0EA - Each50090-70045681ab65-4d76-47a8-a247-95eb581a7cdc12024-02-14
50090-7004-1EA - Each50090-7004dafcd1c2-2626-496a-94b2-e4ce20ba2d2812024-02-14
50090-7004-2EA - Each50090-70049f876a9e-516d-4c17-bffc-3f76a56462b312024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7004ROSUVASTATIN CALCIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]7Current NDC, 3 package rows20240629_e5decd64-cde1-4d8d-9853-7243fb0e1722.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859751rosuvastatin calcium 20 MG Oral TabletPSNe5decd64-cde1-4d8d-9853-7243fb0e17227
859751rosuvastatin calcium 20 MG Oral TabletSCDe5decd64-cde1-4d8d-9853-7243fb0e17227

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7004-05009070040030 TABLET, FILM COATED in 1 BOTTLE (50090-7004-0) 2024-01-02NoNoCurrent
50090-7004-15009070040190 TABLET, FILM COATED in 1 BOTTLE (50090-7004-1) 2024-01-02NoNoCurrent
50090-7004-250090700402100 TABLET, FILM COATED in 1 BOTTLE (50090-7004-2) 2024-01-02NoNoCurrent