Rosuvastatin Calcium

Product NDC
72205-005
11-digit product format
722050005
Labeler code
72205
Product ID
72205-005_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
40 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 CALCIUM40 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
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-005-05Rosuvastatin Calcium500 in 1 BOTTLETABLET, FILM COATED5009
72205-005-06Rosuvastatin Calcium100 in 1 CARTONTABLET, FILM COATED1009
72205-005-11Rosuvastatin Calcium10 in 1 BLISTER PACKTABLET, FILM COATED109
72205-005-30Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED309
72205-005-90Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED909
72205-005-99Rosuvastatin Calcium1000 in 1 BOTTLETABLET, FILM COATED10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-005-30EA - Each72205-0051dd73169-0b52-4ed5-b73c-b63836f40c4212018-09-05
72205-005-90EA - Each72205-005536b11f0-33c6-4962-aaf3-6a5bd84c13f212018-10-11
72205-005-99EA - Each72205-0057290b378-f4de-417b-97db-0678fd20790a12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-005ROSUVASTATIN CALCIUM TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC]9Current NDC, Legacy NDC, 6 package rows20250302_d58f1f63-4bb6-413c-9730-ded3e8078618.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859419rosuvastatin calcium 40 MG Oral TabletPSN8795a783-755d-426b-aa4f-1fc9965ba944101
859419rosuvastatin calcium 40 MG Oral TabletSCD8795a783-755d-426b-aa4f-1fc9965ba944101
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
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
859419rosuvastatin calcium 40 MG Oral TabletPSN8046d4fa-bd89-49f7-8204-9eb49b6487485
859419rosuvastatin calcium 40 MG Oral TabletSCD8046d4fa-bd89-49f7-8204-9eb49b6487485
859419rosuvastatin calcium 40 MG Oral TabletPSNee4f7a00-b330-47ed-8440-7317b43753cf4
859419rosuvastatin calcium 40 MG Oral TabletSCDee4f7a00-b330-47ed-8440-7317b43753cf4
859419rosuvastatin calcium 40 MG Oral TabletPSNdc7bfc79-9ee3-46e7-b55d-aba88648ad3b1
859419rosuvastatin calcium 40 MG Oral TabletSCDdc7bfc79-9ee3-46e7-b55d-aba88648ad3b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-005-0572205000505500 TABLET, FILM COATED in 1 BOTTLE (72205-005-05) 2019-02-250000-00-00NoNoCurrent
72205-005-0672205000506100 BLISTER PACK in 1 CARTON (72205-005-06) / 10 TABLET, FILM COATED in 1 BLISTER PACK (72205-005-11) 100 blister pack2017-11-220000-00-00NoNoCurrent
72205-005-117220500051110 in 1 BLISTER PACKHistorical
72205-005-307220500053030 TABLET, FILM COATED in 1 BOTTLE (72205-005-30) 2017-11-220000-00-00NoNoCurrent
72205-005-907220500059090 TABLET, FILM COATED in 1 BOTTLE (72205-005-90) 2018-09-170000-00-00NoNoCurrent
72205-005-99722050005991000 TABLET, FILM COATED in 1 BOTTLE (72205-005-99) 2017-11-220000-00-00NoNoCurrent