Simvastatin

Product NDC
70934-376
11-digit product format
709340376
Labeler code
70934
Product ID
70934-376_b7af91f3-c0c8-a02d-e053-2a95a90aa0e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA200895
Marketing category
ANDA
Marketing start
2019-05-30
Marketing end
0000-00-00
Substance
SIMVASTATIN
Active strength
40 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
70934-376-902023-02-08C16284748780-1d6a99b39-67a8-a426-e053-dadaa90af4c28a1f5aff-9f44-9ac1-e053-2a95a90a8842
70934-376-902022-01-28C16284748780-1d6a99b39-67a8-a426-e053-dadaa90af4c28a1f5aff-9f44-9ac1-e053-2a95a90a8842

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-376-907093403769090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-376-90) 2019-05-300000-00-00NoNoCurrent