METFORMIN HYDROCHLORIDE

Product NDC
67046-1556
11-digit product format
670461556
Labeler code
67046
Product ID
67046-1556_33ec8828-24ea-8757-e063-6394a90ae222
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METFORMIN HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Coupler LLC
Application
ANDA217631
Marketing category
ANDA
Marketing start
2025-04-29
Substance
METFORMIN HYDROCHLORIDE
Active strength
750 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 formatDescriptionMarketing startSampleExclude flagStatus
67046-1556-36704615560330 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1556-3) 2025-04-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
METFORMIN HYDROCHLORIDECoupler LLC2025-04-29HUMAN PRESCRIPTION DRUG LABEL1