Metformin Hydrochloride

Product NDC
65862-291
11-digit product format
658620291
Labeler code
65862
Product ID
65862-291_f2bf47e5-b110-4574-95ea-21fda63777ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA079118
Marketing category
ANDA
Marketing start
2012-07-20
Marketing end
0000-00-00
Substance
METFORMIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-291-01EA - Each65862-291139f5908-c028-4a02-97da-0a9da72b0a7212013-02-13
65862-291-05EA - Each65862-2910ceda027-f1ee-4dc8-9d8a-25d2f11c302c12013-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-291-0165862029101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65862-291-01) 2012-07-200000-00-00NoNoCurrent
65862-291-0565862029105500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65862-291-05) 2012-07-200000-00-00NoNoCurrent
65862-291-306586202913030 TABLET, EXTENDED RELEASE in 1 BOTTLE (65862-291-30) 2012-07-200000-00-00NoNoCurrent