METFORMIN HYDROCHLORIDE

Product NDC
71610-441
11-digit product format
716100441
Labeler code
71610
Product ID
71610-441_26bddffb-91bc-4305-a698-3df35d7b15d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METFORMIN HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077336
Marketing category
ANDA
Marketing start
2006-02-09
Marketing end
0000-00-00
Substance
METFORMIN HYDROCHLORIDE
Active strength
750 mg/1
Pharmacologic classes
Biguanide [EPC],Biguanides [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-441-53EA - Each71610-441540e3376-26e4-414f-b326-6f3ed38e408412020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-441METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20200709_e97fd756-b5ee-4b6d-a7a9-8fe7fb3c091b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-441-537161004415360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-441-53) 2020-06-240000-00-00NoNoCurrent