SIMVASTATIN

Product NDC
50090-6236
11-digit product format
500906236
Labeler code
50090
Product ID
50090-6236_49db7aa2-71f3-49b5-99cc-8e009f94124f
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
2007-06-12
Substance
SIMVASTATIN
Active strength
10 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
AGG2FN16EVSIMVASTATIN79902-63-9SIMVASTATIN

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6236-05009062360090 TABLET, FILM COATED in 1 BOTTLE (50090-6236-0) 2022-11-21NoNoHistorical
50090-6236-15009062360130 TABLET, FILM COATED in 1 BOTTLE (50090-6236-1) 2022-11-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
SIMVASTATINA-S Medication Solutions2026-03-23HUMAN PRESCRIPTION DRUG LABEL5