METFORMIN HYDROCHLORIDE

Product NDC
71335-2466
11-digit product format
713352466
Labeler code
71335
Product ID
71335-2466_acb90d85-23a7-47cb-b3fb-583c4aee1ccd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metformin hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA213320
Marketing category
ANDA
Marketing start
2023-01-19
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 HYDROCHLORIDE
Listing expiration
2026-12-31

Related Records

Active Ingredients

IngredientStrength
METFORMIN HYDROCHLORIDE500 mg/1

Harmonized Identifiers

FieldValues
Unii786Z46389E
Rxcui861007

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2466-07133524660025 TABLET in 1 BOTTLE (71335-2466-0) 25 tablet2024-08-16NoNoCurrent
71335-2466-17133524660130 TABLET in 1 BOTTLE (71335-2466-1) 30 tablet2024-08-16NoNoCurrent
71335-2466-27133524660260 TABLET in 1 BOTTLE (71335-2466-2) 60 tablet2024-08-16NoNoCurrent
71335-2466-371335246603100 TABLET in 1 BOTTLE (71335-2466-3) 100 tablet2024-08-16NoNoCurrent
71335-2466-471335246604120 TABLET in 1 BOTTLE (71335-2466-4) 120 tablet2024-08-16NoNoCurrent
71335-2466-57133524660590 TABLET in 1 BOTTLE (71335-2466-5) 90 tablet2024-08-16NoNoCurrent
71335-2466-67133524660628 TABLET in 1 BOTTLE (71335-2466-6) 28 tablet2024-08-16NoNoCurrent
71335-2466-77133524660756 TABLET in 1 BOTTLE (71335-2466-7) 56 tablet2024-08-16NoNoCurrent
71335-2466-871335246608180 TABLET in 1 BOTTLE (71335-2466-8) 180 tablet2024-08-16NoNoCurrent
71335-2466-97133524660910 TABLET in 1 BOTTLE (71335-2466-9) 10 tablet2024-08-16NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
METFORMIN HYDROCHLORIDEBryant Ranch Prepack2024-08-16HUMAN PRESCRIPTION DRUG LABEL1