Glimepiride

Product NDC
68788-7694
11-digit product format
687887694
Labeler code
68788
Product ID
68788-7694_4c271a16-4044-42b5-ae29-751d01c57a57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA077091
Marketing category
ANDA
Marketing start
2020-04-01
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
68788-7694-1EA - Each68788-7694459a7340-bc9a-4de6-b70f-b3d6701d077812020-07-13
68788-7694-3EA - Each68788-76941544a3cc-9833-4eab-aac7-d7835ad1ae6312020-07-13
68788-7694-6EA - Each68788-7694c77d5d3c-27e5-4b14-af5a-8c48a293c4f012020-07-13
68788-7694-9EA - Each68788-7694aaa3ef50-6f01-4a2f-b63e-4d431ff058c912020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7694GLIMEPIRIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]5Legacy NDC20240511_fc711cb8-49fb-4562-83e4-b8017030aee5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7694-168788769401100 TABLET in 1 BOTTLE (68788-7694-1) 100 tablet2020-04-010000-00-00NoNoCurrent
68788-7694-36878876940330 TABLET in 1 BOTTLE (68788-7694-3) 30 tablet2020-04-010000-00-00NoNoCurrent
68788-7694-66878876940660 TABLET in 1 BOTTLE (68788-7694-6) 60 tablet2020-04-010000-00-00NoNoCurrent
68788-7694-96878876940990 TABLET in 1 BOTTLE (68788-7694-9) 90 tablet2020-04-010000-00-00NoNoCurrent