Metformin Hydrochloride

Product NDC
43353-128
11-digit product format
433530128
Labeler code
43353
Product ID
43353-128_2ac9368a-7105-4d2a-a6d7-a8b9c5c9bfce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA091184
Marketing category
ANDA
Marketing start
2011-01-31
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
43353-128-60EA - Each43353-1285e662de4-c1ab-4580-95ed-f5bd917928ea12016-07-19
43353-128-80EA - Each43353-128899e7721-a334-4f3a-870b-15dd74e29ed412016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-128METFORMIN HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20160712_3395325a-35bd-4bda-bed3-81eb6153ed12.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-128-604335301286090 TABLET, FILM COATED in 1 BOTTLE (43353-128-60) 2015-12-260000-00-00NoNoCurrent
43353-128-8043353012880180 TABLET, FILM COATED in 1 BOTTLE (43353-128-80) 2015-12-230000-00-00NoNoCurrent