Glyburide and Metformin Hydrochloride

Product NDC
70934-959
11-digit product format
709340959
Labeler code
70934
Product ID
70934-959_d9a6bbd6-baad-e3b4-e053-2995a90a7335
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide and Metformin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA077870
Marketing category
ANDA
Marketing start
2022-03-07
Marketing end
0000-00-00
Substance
GLYBURIDE; METFORMIN HYDROCHLORIDE
Active strength
3 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-959-607093409596060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-959-60) 2022-03-070000-00-00NoNoCurrent