Metformin Hydrochloride

Product NDC
71610-673
11-digit product format
716100673
Labeler code
71610
Product ID
71610-673_2e3c04ee-8af6-4b53-88eb-833fdb555094
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA090564
Marketing category
ANDA
Marketing start
2019-06-26
Substance
METFORMIN HYDROCHLORIDE
Active strength
1000 mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
786Z46389EMETFORMIN HYDROCHLORIDE1115-70-4METFORMIN HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-673-307161006733030 TABLET in 1 BOTTLE (71610-673-30) 30 tablet2022-11-03NoNoHistorical
71610-673-457161006734545 TABLET in 1 BOTTLE (71610-673-45) 45 tablet2022-11-03NoNoHistorical
71610-673-537161006735360 TABLET in 1 BOTTLE (71610-673-53) 60 tablet2022-11-03NoNoHistorical
71610-673-607161006736090 TABLET in 1 BOTTLE (71610-673-60) 90 tablet2022-11-03NoNoHistorical
71610-673-7071610067370120 TABLET in 1 BOTTLE (71610-673-70) 120 tablet2022-11-03NoNoHistorical
71610-673-8071610067380180 TABLET in 1 BOTTLE (71610-673-80) 180 tablet2022-11-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Metformin HydrochlorideAphena Pharma Solutions - Tennessee, LLC2022-11-03HUMAN PRESCRIPTION DRUG LABEL2