Glyburide and Metformin Hydrochloride

Product NDC
68788-9966
11-digit product format
687889966
Labeler code
68788
Product ID
68788-9966_df8e38eb-115e-490c-a9f0-a7990a13138c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide and Metformin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077870
Marketing category
ANDA
Marketing start
2015-05-05
Marketing end
0000-00-00
Substance
GLYBURIDE; METFORMIN HYDROCHLORIDE
Active strength
5 mg/1; mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS],Biguanide [EPC],Biguanides [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-9966-1EA - Each68788-99665a8407e1-8ec4-459d-bffd-63540559367112018-08-13
68788-9966-3EA - Each68788-9966b3d46fa4-8c25-44a3-96bf-8f978a897d5c12018-08-13
68788-9966-6EA - Each68788-9966aebcd5e2-f286-4908-87a1-cbb3267fd4ac12018-08-13
68788-9966-8EA - Each68788-9966e546ebbe-fc2f-4137-8483-a39e492ce06712018-08-13
68788-9966-9EA - Each68788-99668e4bbaf5-d7a9-4eea-8ddd-d3b1f045044112018-08-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-9966-168788996601100 TABLET, FILM COATED in 1 BOTTLE (68788-9966-1) 2015-05-050000-00-00NoNoCurrent
68788-9966-36878899660330 TABLET, FILM COATED in 1 BOTTLE (68788-9966-3) 2015-05-050000-00-00NoNoCurrent
68788-9966-66878899660660 TABLET, FILM COATED in 1 BOTTLE (68788-9966-6) 2015-05-050000-00-00NoNoCurrent
68788-9966-868788996608120 TABLET, FILM COATED in 1 BOTTLE (68788-9966-8) 2015-05-050000-00-00NoNoCurrent
68788-9966-96878899660990 TABLET, FILM COATED in 1 BOTTLE (68788-9966-9) 2015-05-050000-00-00NoNoCurrent