FDA.reportPublic FDA data

Simvastatin

Product NDC
68788-7437
11-digit product format
687887437
Labeler code
68788
Product ID
68788-7437_76748bcb-3217-44f3-9d40-6154fb5cebaf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA076052
Marketing category
ANDA
Marketing start
2006-06-27
Marketing end
2020-05-31
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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7437-1EA - Each68788-743746ac3d23-aa91-48a1-85a9-d96039b4f19512020-04-20
68788-7437-3EA - Each68788-7437374d22f5-ddb9-4c8e-9dd7-b727a1727cbb12020-04-20
68788-7437-6EA - Each68788-7437aa546672-944f-4052-adbe-b101dd1ad47d12020-04-20
68788-7437-9EA - Each68788-7437ff0d3786-f09f-4f63-a8b2-da408a7d187212020-04-20