METFORMIN HYDROCHLORIDE

Product NDC
68788-8560
11-digit product format
687888560
Labeler code
68788
Product ID
68788-8560_a368af83-b612-4e8a-a6c3-a44fba00d85c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metformin hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA213320
Marketing category
ANDA
Marketing start
2024-01-08
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
68788-8560-168788856001100 TABLET in 1 BOTTLE (68788-8560-1) 100 tablet2024-01-08NoNoHistorical
68788-8560-36878885600330 TABLET in 1 BOTTLE (68788-8560-3) 30 tablet2024-01-08NoNoHistorical
68788-8560-66878885600660 TABLET in 1 BOTTLE (68788-8560-6) 60 tablet2024-01-08NoNoHistorical
68788-8560-868788856008120 TABLET in 1 BOTTLE (68788-8560-8) 120 tablet2024-01-08NoNoHistorical
68788-8560-96878885600990 TABLET in 1 BOTTLE (68788-8560-9) 90 tablet2024-01-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
METFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.2025-08-06HUMAN PRESCRIPTION DRUG LABEL2