Metformin Hydrochloride

Product NDC
42291-611
11-digit product format
422910611
Labeler code
42291
Product ID
42291-611_cdc67c16-881f-44d1-e053-2a95a90ab9c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
AvKARE
Application
ANDA078596
Marketing category
ANDA
Marketing start
2010-10-04
Marketing end
0000-00-00
Substance
METFORMIN HYDROCHLORIDE
Active strength
750 mg/1
Pharmacologic classes
Biguanide [EPC],Biguanides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-611-01EA - Each42291-611597184b1-d789-4e4a-9a7c-764b7f78b9b712020-03-10
42291-611-18EA - Each42291-6119c56478b-883f-49db-af43-c9bba2e5115112012-07-24
42291-611-27EA - Each42291-611bdb0944b-0b7a-4fc9-88c7-80de2b07699312014-12-01
42291-611-50EA - Each42291-61115235397-eb9e-411f-8f2d-4eeb99ee2ed612014-12-01
42291-611-90EA - Each42291-61141e7a331-70e6-40fb-b4ac-970f4c66f24612014-12-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-611-0142291061101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-611-01) 2019-10-310000-00-00NoNoCurrent
42291-611-1842291061118180 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-611-18) 2010-10-040000-00-00NoNoCurrent
42291-611-5042291061150500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-611-50) 2014-10-150000-00-00NoNoCurrent
42291-611-904229106119090 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-611-90) 2014-10-150000-00-00NoNoCurrent