Glyburide and Metformin Hydrochloride

Product NDC
0228-2752
11-digit product format
002282752
Labeler code
0228
Product ID
0228-2752_558bd059-6925-46f5-9132-ac6fde1ba07a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide and Metformin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA076716
Marketing category
ANDA
Marketing start
2005-06-28
Marketing end
2022-12-31
Substance
GLYBURIDE; METFORMIN HYDROCHLORIDE
Active strength
3 mg/1; mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
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
0228-2752-11EA - Each0228-27524565a153-78e3-45b8-8ab6-ef8b0130d8b112012-07-24
0228-2752-50EA - Each0228-27522f399c6e-c575-41b4-85ef-438eb654df3812012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0228-2752-1100228275211100 TABLET, FILM COATED in 1 BOTTLE (0228-2752-11) 2005-06-280000-00-00NoNoCurrent
0228-2752-5000228275250500 TABLET, FILM COATED in 1 BOTTLE (0228-2752-50) 2005-06-280000-00-00NoNoCurrent