SIMVASTATIN

Product NDC
61919-764
11-digit product format
619190764
Labeler code
61919
Product ID
61919-764_f215afbc-93ab-1803-e053-2a95a90a4fe1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SIMVASTATIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA078103
Marketing category
ANDA
Marketing start
2021-01-18
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
2024-12-31
Current FDA listing
Historical FDA.report record

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314231simvastatin 10 MG Oral TabletPSNe92b873a-0ccc-4852-845b-e27e5daab40e13
198211simvastatin 40 MG Oral TabletPSNe92b873a-0ccc-4852-845b-e27e5daab40e13
200345simvastatin 80 MG Oral TabletPSNe92b873a-0ccc-4852-845b-e27e5daab40e13
314231simvastatin 10 MG Oral TabletSCDe92b873a-0ccc-4852-845b-e27e5daab40e13
198211simvastatin 40 MG Oral TabletSCDe92b873a-0ccc-4852-845b-e27e5daab40e13
200345simvastatin 80 MG Oral TabletSCDe92b873a-0ccc-4852-845b-e27e5daab40e13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-764-906191907649090 TABLET, FILM COATED in 1 BOTTLE (61919-764-90) 2021-01-180000-00-00NoNoCurrent