Simvastatin

Product NDC
63629-1199
11-digit product format
636291199
Labeler code
63629
Product ID
63629-1199_72c726e9-5ca6-4cb0-b6fb-1df52f00937d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078034
Marketing category
ANDA
Marketing start
2015-12-17
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1199-1EA - Each63629-11990448c89d-bd98-4099-9b4a-714f25ce8d3e12021-02-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-1199-1636291199011000 TABLET, FILM COATED in 1 BOTTLE (63629-1199-1) 2015-12-170000-00-00NoNoCurrent