FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
72205-002
11-digit product format
722050002
Labeler code
72205
Product ID
72205-002_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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-002-05Rosuvastatin Calcium500 in 1 BOTTLETABLET, FILM COATED5009
72205-002-06Rosuvastatin Calcium100 in 1 CARTONTABLET, FILM COATED1009
72205-002-11Rosuvastatin Calcium10 in 1 BLISTER PACKTABLET, FILM COATED109
72205-002-90Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED909
72205-002-99Rosuvastatin Calcium1000 in 1 BOTTLETABLET, FILM COATED10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-002-90EA - Each72205-0024af0a0f0-0336-490b-9b35-43160a60214212018-09-05
72205-002-99EA - Each72205-002cba0fd87-ed3f-40c6-a25a-f6a4436124b912018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-002ROSUVASTATIN 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
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
859424rosuvastatin calcium 5 MG Oral TabletPSNd6645266-9626-430e-bf04-b6426525ae0a9
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 TabletSCDd6645266-9626-430e-bf04-b6426525ae0a9
859751rosuvastatin calcium 20 MG Oral TabletPSN7a8db339-b98c-6fab-e053-2a91aa0a12473
859419rosuvastatin calcium 40 MG Oral TabletPSN7a8db339-b98c-6fab-e053-2a91aa0a12473
859424rosuvastatin calcium 5 MG Oral TabletPSN7a8db339-b98c-6fab-e053-2a91aa0a12473
859751rosuvastatin calcium 20 MG Oral TabletSCD7a8db339-b98c-6fab-e053-2a91aa0a12473
859419rosuvastatin calcium 40 MG Oral TabletSCD7a8db339-b98c-6fab-e053-2a91aa0a12473
859424rosuvastatin calcium 5 MG Oral TabletSCD7a8db339-b98c-6fab-e053-2a91aa0a12473

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-002-0572205000205500 TABLET, FILM COATED in 1 BOTTLE (72205-002-05) 2019-02-252022-01-31NoNoCurrent
72205-002-0672205000206100 BLISTER PACK in 1 CARTON (72205-002-06) > 10 TABLET, FILM COATED in 1 BLISTER PACK (72205-002-11) 100 blister pack2017-11-222022-01-31NoNoCurrent
72205-002-117220500021110 in 1 BLISTER PACKHistorical
72205-002-907220500029090 TABLET, FILM COATED in 1 BOTTLE (72205-002-90) 2017-11-222022-01-31NoNoCurrent
72205-002-99722050002991000 TABLET, FILM COATED in 1 BOTTLE (72205-002-99) 2017-11-222022-01-31NoNoCurrent