Metformin HCl

Product NDC
71205-562
11-digit product format
712050562
Labeler code
71205
Product ID
71205-562_09678d2f-39cd-4821-bcac-3ecdc853f822
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin HCl
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090564
Marketing category
ANDA
Marketing start
2017-02-06
Substance
METFORMIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data

Finished product
Yes
Brand name base
Metformin HCl
Listing expiration
2026-12-31

Related Records

Active Ingredients

IngredientStrength
METFORMIN HYDROCHLORIDE500 mg/1

Harmonized Identifiers

FieldValues
Unii786Z46389E
Rxcui861007, 861010

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-562-0071205056200100 TABLET in 1 BOTTLE (71205-562-00) 100 tablet2021-06-230000-00-00NoNoCurrent
71205-562-307120505623030 TABLET in 1 BOTTLE (71205-562-30) 30 tablet2021-05-170000-00-00NoNoCurrent
71205-562-607120505626060 TABLET in 1 BOTTLE (71205-562-60) 60 tablet2021-05-170000-00-00NoNoCurrent
71205-562-907120505629090 TABLET in 1 BOTTLE (71205-562-90) 90 tablet2021-05-170000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Metformin Hydrochloride Tablets USPProficient Rx LP2022-06-01HUMAN PRESCRIPTION DRUG LABEL3