SIMVASTATIN

Product NDC
50090-5788
11-digit product format
500905788
Labeler code
50090
Product ID
50090-5788_21cfbad6-22fc-424a-87a4-3f4fef24b382
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SIMVASTATIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078103
Marketing category
ANDA
Marketing start
2016-01-05
Marketing end
0000-00-00
Substance
SIMVASTATIN
Active strength
80 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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5347abc9-d72b-9efb-f582-cc87efafcf1bProduct name420250729
c4422d73-8e69-1539-606a-32a25fa00ebcProduct name420190926
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6Product name120160615
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5788SIMVASTATIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC20230208_e447cc46-adee-4126-8b85-f00f81a6e93c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5788-05009057880030 TABLET, FILM COATED in 1 BOTTLE (50090-5788-0) 2021-10-080000-00-00NoNoCurrent
50090-5788-15009057880190 TABLET, FILM COATED in 1 BOTTLE (50090-5788-1) 2021-10-080000-00-00NoNoCurrent