Metformin Hydrochloride

Product NDC
65162-218
11-digit product format
651620218
Labeler code
65162
Product ID
65162-218_cbbbd23f-982c-4f27-89c6-2568a283aecd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA077880
Marketing category
ANDA
Marketing start
2012-12-17
Marketing end
0000-00-00
Substance
METFORMIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-218-10EA - Each65162-2182da214ac-15e1-4b44-8fdb-343d10dda48f12013-02-11
65162-218-11EA - Each65162-21862c27e46-ebdd-472b-b94d-f770b9d599e712013-02-11
65162-218-50EA - Each65162-21871caea63-2a63-4b1a-9f72-2236fa64289512013-02-11

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-218METFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS LLC]19Legacy NDC20241031_14544c2f-88c8-48a5-941e-48a543d7baaa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-218-036516202180330 TABLET in 1 BOTTLE (65162-218-03) 30 tablet2012-12-170000-00-00NoNoCurrent
65162-218-1065162021810100 TABLET in 1 BOTTLE (65162-218-10) 100 tablet2012-12-170000-00-00NoNoCurrent
65162-218-11651620218111000 TABLET in 1 BOTTLE (65162-218-11) 1000 tablet2012-12-170000-00-00NoNoCurrent
65162-218-5065162021850500 TABLET in 1 BOTTLE (65162-218-50) 500 tablet2012-12-170000-00-00NoNoCurrent