glyburide-metformin hydrochloride

Product NDC
50090-7514
11-digit product format
500907514
Labeler code
50090
Product ID
50090-7514_3c0006ae-e263-40a5-a8bc-ab5a20b7858d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glyburide-metformin hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA079009
Marketing category
ANDA
Marketing start
2024-05-01
Substance
GLYBURIDE; METFORMIN HYDROCHLORIDE
Active strength
5; 500 mg/1; mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
SX6K58TVWCGLYBURIDE10238-21-8GLYBURIDE
786Z46389EMETFORMIN HYDROCHLORIDE1115-70-4METFORMIN HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7514-05009075140060 TABLET in 1 BOTTLE (50090-7514-0) 60 tablet2025-03-03NoNoHistorical
50090-7514-250090751402100 TABLET in 1 BOTTLE (50090-7514-2) 100 tablet2025-03-03NoNoHistorical
50090-7514-35009075140390 TABLET in 1 BOTTLE (50090-7514-3) 90 tablet2025-03-03NoNoHistorical
50090-7514-450090751404180 TABLET in 1 BOTTLE (50090-7514-4) 180 tablet2025-03-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
glyburide-metformin hydrochlorideA-S Medication Solutions2026-03-03HUMAN PRESCRIPTION DRUG LABEL4