Glimepiride

Product NDC
68645-572
11-digit product format
686450572
Labeler code
68645
Product ID
68645-572_efa8480d-e214-21ca-e053-2a95a90a0e1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Legacy Pharmaceutical Packaging, LLC
Application
ANDA077091
Marketing category
ANDA
Marketing start
2005-10-06
Marketing end
0000-00-00
Substance
GLIMEPIRIDE
Active strength
2 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
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
68645-572-90EA - Each68645-5721568fdc9-8d97-4bc0-b662-435036c6753712018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68645-572GLIMEPIRIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC]7Legacy NDC20250321_11d62bd7-033f-4ce4-a666-dbe575119ec3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68645-572-906864505729090 TABLET in 1 BOTTLE (68645-572-90) 90 tablet2005-10-060000-00-00NoNoCurrent