Glyburide and Metformin Hydrochloride

Product NDC
50268-357
11-digit product format
502680357
Labeler code
50268
Product ID
50268-357_df223cca-4b2e-431a-e053-2a95a90a8d1d
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
2021-02-15
Marketing end
0000-00-00
Substance
GLYBURIDE; METFORMIN HYDROCHLORIDE
Active strength
5 mg/1; mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-357-11EA - Each50268-357f4c9e2be-33a4-403b-9cc0-cea3f642087412021-03-02
50268-357-15EA - Each50268-357d94c9478-2a5b-498e-b6c6-31c830f689ba12021-03-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-357-155026803571550 BLISTER PACK in 1 BOX (50268-357-15) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-357-11) 50 blister pack2021-02-150000-00-00NoNoCurrent