METFORMIN HYDROCHLORIDE

Product NDC
71610-672
11-digit product format
716100672
Labeler code
71610
Product ID
71610-672_f37e1ca3-ffdc-4b2c-bfe4-975e4121d2c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METFORMIN HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA203769
Marketing category
ANDA
Marketing start
2015-02-01
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
71610-672-307161006723030 TABLET in 1 BOTTLE (71610-672-30) 30 tablet2022-11-02NoNoHistorical
71610-672-457161006724545 TABLET in 1 BOTTLE (71610-672-45) 45 tablet2022-11-02NoNoHistorical
71610-672-537161006725360 TABLET in 1 BOTTLE (71610-672-53) 60 tablet2022-11-02NoNoHistorical
71610-672-607161006726090 TABLET in 1 BOTTLE (71610-672-60) 90 tablet2022-11-02NoNoHistorical
71610-672-7071610067270120 TABLET in 1 BOTTLE (71610-672-70) 120 tablet2022-11-02NoNoHistorical
71610-672-8071610067280180 TABLET in 1 BOTTLE (71610-672-80) 180 tablet2022-11-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
METFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC2022-11-03HUMAN PRESCRIPTION DRUG LABEL1