Rosuvastatin

Product NDC
70934-440
11-digit product format
709340440
Labeler code
70934
Product ID
70934-440_a1859f3e-f1ed-04ed-e053-2a95a90a5ab6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA207616
Marketing category
ANDA
Marketing start
2019-09-11
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
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70934-440-302023-02-07C16284748780-1d6a99b39-c78d-a426-e053-dadaa90af4c2a1859f3e-f1ec-04ed-e053-2a95a90a5ab6
70934-440-302022-01-28C16284748780-1d6a99b39-c78d-a426-e053-dadaa90af4c2a1859f3e-f1ec-04ed-e053-2a95a90a5ab6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-440-307093404403030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-440-30) 2019-09-110000-00-00NoNoCurrent