glyburide-metformin hydrochloride

Product NDC
50090-7814
11-digit product format
500907814
Labeler code
50090
Product ID
50090-7814_16b2602c-1227-49a6-b7fa-ee94c31bb05e
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
2.5; 500 mg/1; mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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
50090-7814-05009078140060 TABLET in 1 BOTTLE (50090-7814-0) 60 tablet2025-12-09NoNoHistorical
50090-7814-250090781402180 TABLET in 1 BOTTLE (50090-7814-2) 180 tablet2025-12-09NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
glyburide-metformin hydrochlorideA-S Medication Solutions2025-12-12HUMAN PRESCRIPTION DRUG LABEL3