Simvastatin

Product NDC
71205-070
11-digit product format
712050070
Labeler code
71205
Product ID
71205-070_1bfa53ed-bcef-4864-81b9-e36a2016a7d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076052
Marketing category
ANDA
Marketing start
2006-06-27
Marketing end
0000-00-00
Substance
SIMVASTATIN
Active strength
5 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-070-90EA - Each71205-07001a23710-bd72-436f-a796-54c54560638412018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-070SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]2Legacy NDC20191030_4615c9f1-04f5-4eb7-9a8d-cbb703772adb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-070-307120500703030 TABLET, FILM COATED in 1 BOTTLE (71205-070-30) 2018-07-020000-00-00NoNoCurrent
71205-070-607120500706060 TABLET, FILM COATED in 1 BOTTLE (71205-070-60) 2018-07-020000-00-00NoNoCurrent
71205-070-907120500709090 TABLET, FILM COATED in 1 BOTTLE (71205-070-90) 2018-07-020000-00-00NoNoCurrent