FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
72205-027
11-digit product format
722050027
Labeler code
72205
Product ID
72205-027_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
5 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 CALCIUM5 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
72205-027-05Rosuvastatin Calcium500 in 1 BOTTLETABLET, FILM COATED5009
72205-027-06Rosuvastatin Calcium100 in 1 CARTONTABLET, FILM COATED1009
72205-027-11Rosuvastatin Calcium10 in 1 BLISTER PACKTABLET, FILM COATED109
72205-027-90Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED909
72205-027-99Rosuvastatin Calcium1000 in 1 BOTTLETABLET, FILM COATED10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-027-90EA - Each72205-027e8d0adcb-607b-42ff-8744-a7f4c1d9d53112019-06-19
72205-027-99EA - Each72205-0276407e2a7-63cf-4956-afb0-bd738b90b19612019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-027ROSUVASTATIN 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
859424rosuvastatin calcium 5 MG Oral TabletPSN199df185-dab0-4de1-95f7-a70e57b9c2b1102
859424rosuvastatin calcium 5 MG Oral TabletSCD199df185-dab0-4de1-95f7-a70e57b9c2b1102
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 TabletPSNaaadbf01-9cf4-4898-9a96-f0a20d55702b9
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
859424rosuvastatin calcium 5 MG Oral TabletSCDaaadbf01-9cf4-4898-9a96-f0a20d55702b9
859419rosuvastatin calcium 40 MG Oral TabletPSN99602058-4681-7cb5-e053-2995a90a099c7
859424rosuvastatin calcium 5 MG Oral TabletPSN99602058-4681-7cb5-e053-2995a90a099c7
859419rosuvastatin calcium 40 MG Oral TabletSCD99602058-4681-7cb5-e053-2995a90a099c7
859424rosuvastatin calcium 5 MG Oral TabletSCD99602058-4681-7cb5-e053-2995a90a099c7
859424rosuvastatin calcium 5 MG Oral TabletPSN7ec15f53-a7ec-4be5-9f26-d1078117b18b6
859424rosuvastatin calcium 5 MG Oral TabletSCD7ec15f53-a7ec-4be5-9f26-d1078117b18b6
859424rosuvastatin calcium 5 MG Oral TabletPSNa2155aff-bf13-3f00-e053-2995a90a4d1d3
859424rosuvastatin calcium 5 MG Oral TabletPSN31b3894a-1139-4f07-ac29-dda53844dc4b3
859424rosuvastatin calcium 5 MG Oral TabletSCDa2155aff-bf13-3f00-e053-2995a90a4d1d3
859424rosuvastatin calcium 5 MG Oral TabletSCD31b3894a-1139-4f07-ac29-dda53844dc4b3
859424rosuvastatin calcium 5 MG Oral TabletPSNf77e97f3-aaed-0cd5-e053-6294a90aa3952
859424rosuvastatin calcium 5 MG Oral TabletSCDf77e97f3-aaed-0cd5-e053-6294a90aa3952

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-027-0572205002705500 TABLET, FILM COATED in 1 BOTTLE (72205-027-05) 2019-05-080000-00-00NoNoCurrent
72205-027-0672205002706100 BLISTER PACK in 1 CARTON (72205-027-06) / 10 TABLET, FILM COATED in 1 BLISTER PACK (72205-027-11) 100 blister pack2019-05-080000-00-00NoNoCurrent
72205-027-117220500271110 in 1 BLISTER PACKHistorical
72205-027-907220500279090 TABLET, FILM COATED in 1 BOTTLE (72205-027-90) 2019-05-080000-00-00NoNoCurrent
72205-027-99722050027991000 TABLET, FILM COATED in 1 BOTTLE (72205-027-99) 2019-05-080000-00-00NoNoCurrent