FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
68788-8775
11-digit product format
687888775
Labeler code
68788
Product ID
68788-8775_4cc2c315-3e54-42b7-9cfb-c5606b470bb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA207626
Marketing category
ANDA
Marketing start
2024-11-22
Substance
ROSUVASTATIN CALCIUM
Active strength
10 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rosuvastatin Calcium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN CALCIUM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83MVU38M7Q
Rxcui859747

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
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
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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
68788-8775-2Rosuvastatin Calcium20 in 1 BOTTLETABLET203
68788-8775-3Rosuvastatin Calcium30 in 1 BOTTLETABLET303
68788-8775-4Rosuvastatin Calcium60 in 1 BOTTLETABLET603
68788-8775-5Rosuvastatin Calcium90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8775-2EA - Each68788-87756fdc8b63-1218-4fb1-8533-1e18d26c376412025-02-10
68788-8775-3EA - Each68788-87755dd2d785-f023-493f-a278-fb6b5c0cd9b212025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8775ROSUVASTATIN CALCIUM TABLET [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 4 package rows20241211_60d52228-f74f-46eb-85d2-e6b0cbb36092.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN60d52228-f74f-46eb-85d2-e6b0cbb360923
859747rosuvastatin calcium 10 MG Oral TabletSCD60d52228-f74f-46eb-85d2-e6b0cbb360923

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8775-26878887750220 TABLET in 1 BOTTLE (68788-8775-2) 20 tablet2024-11-22NoNoHistorical
68788-8775-36878887750330 TABLET in 1 BOTTLE (68788-8775-3) 30 tablet2024-11-22NoNoHistorical
68788-8775-46878887750460 TABLET in 1 BOTTLE (68788-8775-4) 60 tablet2024-11-22NoNoHistorical
68788-8775-56878887750590 TABLET in 1 BOTTLE (68788-8775-5) 90 tablet2024-11-22NoNoHistorical