Metformin Hydrochloride

Product NDC
43353-114
11-digit product format
433530114
Labeler code
43353
Product ID
43353-114_54921df4-d3d6-4ab2-aaf9-9789679c9f99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077095
Marketing category
ANDA
Marketing start
2005-01-14
Marketing end
0000-00-00
Substance
METFORMIN HYDROCHLORIDE
Active strength
1000 mg/1
Pharmacologic classes
Biguanide [EPC],Biguanides [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-114-80EA - Each43353-1143d15abe8-2fc3-4756-ae1c-3b41aab0008c12016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-114METFORMIN HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20160712_d9e1da2c-3582-4714-9904-873472eda84b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-114-8043353011480180 TABLET, FILM COATED in 1 BOTTLE (43353-114-80) 2015-11-040000-00-00NoNoCurrent