Rosuvastatin

Product NDC
68788-7673
11-digit product format
687887673
Labeler code
68788
Product ID
68788-7673_83353bc1-a915-40b2-8269-1fc2526d99d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA207616
Marketing category
ANDA
Marketing start
2020-02-28
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
68788-7673-2EA - Each68788-76731ac8ac6d-6ad8-4a27-8838-a0d2061133da12020-05-08
68788-7673-3EA - Each68788-76738ca271e1-aabd-4527-a469-4f2c0aa3f5b012020-05-08
68788-7673-6EA - Each68788-767303cb5bd7-3254-4176-b58b-fb22b975538312020-05-08
68788-7673-9EA - Each68788-7673efa39669-fc4b-4e21-b0e1-2eb7d8372fbb12020-05-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7673-26878876730220 TABLET, FILM COATED in 1 BOTTLE (68788-7673-2) 2020-02-280000-00-00NoNoCurrent
68788-7673-36878876730330 TABLET, FILM COATED in 1 BOTTLE (68788-7673-3) 2020-02-280000-00-00NoNoCurrent
68788-7673-66878876730660 TABLET, FILM COATED in 1 BOTTLE (68788-7673-6) 2020-02-280000-00-00NoNoCurrent
68788-7673-96878876730990 TABLET, FILM COATED in 1 BOTTLE (68788-7673-9) 2020-02-280000-00-00NoNoCurrent