Rosuvastatin Calcium

Product NDC
68071-2378
11-digit product format
680712378
Labeler code
68071
Product ID
68071-2378_be749534-e424-ab69-e053-2995a90a687f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA208898
Marketing category
ANDA
Marketing start
2017-11-22
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2378-22023-01-30C16284748780-1f386c64a-3ea1-0266-e053-dadaa90a7c1abe749c73-c659-dec1-e053-2995a90ae2a3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2378ROSUVASTATIN CALCIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC20210327_be749c73-c659-dec1-e053-2995a90ae2a3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2378-268071237802120 TABLET, FILM COATED in 1 BOTTLE (68071-2378-2) 2021-03-260000-00-00NoNoCurrent