Metformin Hydrochloride

Product NDC
42806-215
11-digit product format
428060215
Labeler code
42806
Product ID
42806-215_ac5505c5-6cb7-4918-8eb7-433923ff02ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA075965
Marketing category
ANDA
Marketing start
2016-04-01
Marketing end
2023-08-31
Substance
METFORMIN HYDROCHLORIDE
Active strength
850 mg/1
Pharmacologic classes
Biguanide [EPC],Biguanides [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-215-01EA - Each42806-215e890792b-9835-4fe2-bfa9-7aa11770f71012016-07-19
42806-215-05EA - Each42806-21568ec6860-dd43-4b82-af91-bb9c77c283a412016-06-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42806-215-0142806021501100 TABLET, FILM COATED in 1 BOTTLE (42806-215-01) 2016-04-010000-00-00NoNoCurrent
42806-215-0542806021505500 TABLET, FILM COATED in 1 BOTTLE (42806-215-05) 2016-04-010000-00-00NoNoCurrent