Glyburide and Metformin Hydrochloride

Product NDC
50268-355
11-digit product format
502680355
Labeler code
50268
Product ID
50268-355_d22f5899-6340-96c5-e053-2a95a90a65f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide and Metformin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA077870
Marketing category
ANDA
Marketing start
2021-12-02
Marketing end
0000-00-00
Substance
GLYBURIDE; METFORMIN HYDROCHLORIDE
Active strength
1 mg/1; mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS],Biguanide [EPC],Biguanides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-355-155026803551550 BLISTER PACK in 1 BOX (50268-355-15) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-355-11) 50 blister pack2021-12-020000-00-00NoNoCurrent