FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
68788-4047
11-digit product format
687884047
Labeler code
68788
Product ID
68788-4047_1eb971e3-de67-46ae-a8ef-8a7d2805cfdd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA207626
Marketing category
ANDA
Marketing start
2025-10-28
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
Rxcui859751

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
68788-4047-2Rosuvastatin Calcium20 in 1 BOTTLETABLET201
68788-4047-3Rosuvastatin Calcium30 in 1 BOTTLETABLET301
68788-4047-6Rosuvastatin Calcium60 in 1 BOTTLETABLET601
68788-4047-9Rosuvastatin Calcium90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4047-2EA - Each68788-40472ae4e3e8-4348-4c93-9f05-2814bd815e0812026-03-17
68788-4047-3EA - Each68788-40470950cf3b-8b95-49aa-9afe-8bdee4006c5912026-03-17
68788-4047-6EA - Each68788-4047824a74b0-9cc2-4e0a-8a54-1a98c989a2bf12026-03-17
68788-4047-9EA - Each68788-4047796db6f6-539c-462e-956c-21696021924512026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859751rosuvastatin calcium 20 MG Oral TabletPSN1eb971e3-de67-46ae-a8ef-8a7d2805cfdd1
859751rosuvastatin calcium 20 MG Oral TabletSCD1eb971e3-de67-46ae-a8ef-8a7d2805cfdd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-4047-26878840470220 TABLET in 1 BOTTLE (68788-4047-2) 20 tablet2025-10-28NoNoCurrent
68788-4047-36878840470330 TABLET in 1 BOTTLE (68788-4047-3) 30 tablet2025-10-28NoNoCurrent
68788-4047-66878840470660 TABLET in 1 BOTTLE (68788-4047-6) 60 tablet2025-10-28NoNoCurrent
68788-4047-96878840470990 TABLET in 1 BOTTLE (68788-4047-9) 90 tablet2025-10-28NoNoCurrent