Metformin Hydrochloride

Product NDC
42385-904
11-digit product format
423850904
Labeler code
42385
Product ID
42385-904_2c0747fd-dbaa-4e08-bbcf-317f14eda820
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Laurus Labs Limited
Application
ANDA209882
Marketing category
ANDA
Marketing start
2019-01-15
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42385-904-10EA - Each42385-904ee992fa4-8777-49e7-a538-1454a6c5431912019-03-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42385-904-0142385090401100 TABLET, FILM COATED in 1 BOTTLE (42385-904-01) 2019-01-150000-00-00NoNoCurrent
42385-904-0542385090405500 TABLET, FILM COATED in 1 BOTTLE (42385-904-05) 2019-01-150000-00-00NoNoCurrent
42385-904-094238509040990 TABLET, FILM COATED in 1 BOTTLE (42385-904-09) 2019-01-150000-00-00NoNoCurrent
42385-904-10423850904101000 TABLET, FILM COATED in 1 BOTTLE (42385-904-10) 2019-01-150000-00-00NoNoCurrent