Rosuvastatin Calcium

Product NDC
68788-7947
11-digit product format
687887947
Labeler code
68788
Product ID
68788-7947_6a9ce067-37a9-494b-95ec-62fd92ce5c0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA206465
Marketing category
ANDA
Marketing start
2021-06-29
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7947-2EA - Each68788-7947dd507e39-84f8-42ac-a1b1-374c91294a4e12021-07-15
68788-7947-3EA - Each68788-79471c864b9a-4d30-436e-a5af-f1cc6eebcf2c12021-07-15
68788-7947-6EA - Each68788-7947e814f20f-5f77-4c73-888f-b1872dc774ae12021-07-15
68788-7947-9EA - Each68788-7947b1782d05-e989-4b7c-a59e-361cb5f407a112021-07-15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7947-26878879470220 TABLET, FILM COATED in 1 BOTTLE (68788-7947-2) 2021-06-290000-00-00NoNoCurrent
68788-7947-36878879470330 TABLET, FILM COATED in 1 BOTTLE (68788-7947-3) 2021-06-290000-00-00NoNoCurrent
68788-7947-66878879470660 TABLET, FILM COATED in 1 BOTTLE (68788-7947-6) 2021-06-290000-00-00NoNoCurrent
68788-7947-96878879470990 TABLET, FILM COATED in 1 BOTTLE (68788-7947-9) 2021-06-290000-00-00NoNoCurrent