Glyburide and Metformin Hydrochloride

Product NDC
50268-356
11-digit product format
502680356
Labeler code
50268
Product ID
50268-356_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
3 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-356-11EA - Each50268-3561baa6b8c-7201-4704-8b81-1a99df33520712022-01-06
50268-356-15EA - Each50268-356a58927d4-854a-4169-85c8-968e3eaa3b5312022-01-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-356-155026803561550 BLISTER PACK in 1 BOX (50268-356-15) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-356-11) 50 blister pack2021-12-020000-00-00NoNoCurrent