Metformin Hydrochloride

Product NDC
42385-903
11-digit product format
423850903
Labeler code
42385
Product ID
42385-903_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
850 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42385-903-0142385090301100 TABLET, FILM COATED in 1 BOTTLE (42385-903-01) 2019-01-150000-00-00NoNoCurrent
42385-903-0542385090305500 TABLET, FILM COATED in 1 BOTTLE (42385-903-05) 2019-01-150000-00-00NoNoCurrent
42385-903-094238509030990 TABLET, FILM COATED in 1 BOTTLE (42385-903-09) 2019-01-150000-00-00NoNoCurrent
42385-903-10423850903101000 TABLET, FILM COATED in 1 BOTTLE (42385-903-10) 2019-01-150000-00-00NoNoCurrent