Metformin HCl

Product NDC
72789-192
11-digit product format
727890192
Labeler code
72789
Product ID
72789-192_373a1d26-a38f-a2c2-e063-6394a90a7403
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin HCl
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-192-207278901922020 TABLET in 1 BOTTLE, PLASTIC (72789-192-20) 20 tablet2021-12-07NoNoHistorical
72789-192-217278901922121 TABLET in 1 BOTTLE, PLASTIC (72789-192-21) 21 tablet2022-08-30NoNoHistorical
72789-192-307278901923030 TABLET in 1 BOTTLE, PLASTIC (72789-192-30) 30 tablet2021-08-06NoNoHistorical
72789-192-607278901926060 TABLET in 1 BOTTLE, PLASTIC (72789-192-60) 60 tablet2021-08-17NoNoHistorical
72789-192-907278901929090 TABLET in 1 BOTTLE, PLASTIC (72789-192-90) 90 tablet2021-06-14NoNoHistorical
72789-192-9372789019293180 TABLET in 1 BOTTLE, PLASTIC (72789-192-93) 180 tablet2021-06-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Metformin Hydrochloride Tablets USPPD-Rx Pharmaceuticals, Inc.2025-06-10HUMAN PRESCRIPTION DRUG LABEL13