FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
72205-004
11-digit product format
722050004
Labeler code
72205
Product ID
72205-004_62787a4a-6d53-43a3-a0b7-ed0b6037d18e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA208898
Marketing category
ANDA
Marketing start
2017-11-22
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
Rxcui859419, 859424, 859747, 859751

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-004-05Rosuvastatin Calcium500 in 1 BOTTLETABLET, FILM COATED5009
72205-004-06Rosuvastatin Calcium100 in 1 CARTONTABLET, FILM COATED1009
72205-004-11Rosuvastatin Calcium10 in 1 BLISTER PACKTABLET, FILM COATED109
72205-004-90Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED909
72205-004-99Rosuvastatin Calcium1000 in 1 BOTTLETABLET, FILM COATED10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-004-90EA - Each72205-004848afec5-a312-4733-9741-5d1afc9253e712018-09-05
72205-004-99EA - Each72205-00458e639e4-403c-4d60-ba78-9e160e86698d12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-004ROSUVASTATIN CALCIUM TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC]9Current NDC, Legacy NDC, 5 package rows20250302_d58f1f63-4bb6-413c-9730-ded3e8078618.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859751rosuvastatin calcium 20 MG Oral TabletPSNa9a5641f-9b7d-4a98-8dac-a3c53dde861f102
859751rosuvastatin calcium 20 MG Oral TabletSCDa9a5641f-9b7d-4a98-8dac-a3c53dde861f102
859751rosuvastatin calcium 20 MG Oral TabletPSN11fad602-16c2-4c1f-bdf1-867d95f063ca14
859751rosuvastatin calcium 20 MG Oral TabletSCD11fad602-16c2-4c1f-bdf1-867d95f063ca14
859747rosuvastatin calcium 10 MG Oral TabletPSNd58f1f63-4bb6-413c-9730-ded3e80786189
859751rosuvastatin calcium 20 MG Oral TabletPSNd58f1f63-4bb6-413c-9730-ded3e80786189
859419rosuvastatin calcium 40 MG Oral TabletPSNd58f1f63-4bb6-413c-9730-ded3e80786189
859424rosuvastatin calcium 5 MG Oral TabletPSNd58f1f63-4bb6-413c-9730-ded3e80786189
859747rosuvastatin calcium 10 MG Oral TabletSCDd58f1f63-4bb6-413c-9730-ded3e80786189
859751rosuvastatin calcium 20 MG Oral TabletSCDd58f1f63-4bb6-413c-9730-ded3e80786189
859419rosuvastatin calcium 40 MG Oral TabletSCDd58f1f63-4bb6-413c-9730-ded3e80786189
859424rosuvastatin calcium 5 MG Oral TabletSCDd58f1f63-4bb6-413c-9730-ded3e80786189
859751rosuvastatin calcium 20 MG Oral TabletPSN6ef51f7c-2899-4b09-bf8b-09e5b4ac34246
859751rosuvastatin calcium 20 MG Oral TabletSCD6ef51f7c-2899-4b09-bf8b-09e5b4ac34246
859751rosuvastatin calcium 20 MG Oral TabletPSNe24da1b9-e51d-489a-85f4-43227c2104774
859751rosuvastatin calcium 20 MG Oral TabletPSNe3d92523-2dbe-930b-e053-2a95a90ac3f24
859751rosuvastatin calcium 20 MG Oral TabletSCDe24da1b9-e51d-489a-85f4-43227c2104774
859751rosuvastatin calcium 20 MG Oral TabletSCDe3d92523-2dbe-930b-e053-2a95a90ac3f24
859751rosuvastatin calcium 20 MG Oral TabletPSNbe73cea2-f89a-e4c5-e053-2a95a90a9cce2
859751rosuvastatin calcium 20 MG Oral TabletSCDbe73cea2-f89a-e4c5-e053-2a95a90a9cce2
859751rosuvastatin calcium 20 MG Oral TabletPSN3a03022c-ef11-4a68-829f-fae2d31969df1
859751rosuvastatin calcium 20 MG Oral TabletSCD3a03022c-ef11-4a68-829f-fae2d31969df1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-004-0572205000405500 TABLET, FILM COATED in 1 BOTTLE (72205-004-05) 2019-02-250000-00-00NoNoCurrent
72205-004-0672205000406100 BLISTER PACK in 1 CARTON (72205-004-06) / 10 TABLET, FILM COATED in 1 BLISTER PACK (72205-004-11) 100 blister pack2017-11-220000-00-00NoNoCurrent
72205-004-117220500041110 in 1 BLISTER PACKHistorical
72205-004-907220500049090 TABLET, FILM COATED in 1 BOTTLE (72205-004-90) 2017-11-220000-00-00NoNoCurrent
72205-004-99722050004991000 TABLET, FILM COATED in 1 BOTTLE (72205-004-99) 2017-11-220000-00-00NoNoCurrent