Metformin Hydrochloride

Product NDC
42806-213
11-digit product format
428060213
Labeler code
42806
Product ID
42806-213_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
500 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
42806-213-05EA - Each42806-213814fdb6a-b359-4f16-b127-64dfec6778b212016-07-19
42806-213-10EA - Each42806-21344e95273-93e7-4598-a752-97c24ba5314212016-06-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42806-213-0142806021301100 TABLET, FILM COATED in 1 BOTTLE (42806-213-01) 2016-04-012022-10-31NoNoCurrent
42806-213-0542806021305500 TABLET, FILM COATED in 1 BOTTLE (42806-213-05) 2016-04-012023-08-31NoNoCurrent
42806-213-10428060213101000 TABLET, FILM COATED in 1 BOTTLE (42806-213-10) 2016-04-012022-10-31NoNoCurrent