Metformin Hydrochloride

Product NDC
71610-020
11-digit product format
716100020
Labeler code
71610
Product ID
71610-020_8b03af98-aba5-409a-9ff9-102f342bbe4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078596
Marketing category
ANDA
Marketing start
2009-12-02
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
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
71610-020-60EA - Each71610-020be3c1250-3398-482e-b711-2fc94398f6a112018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-020METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Legacy NDC20190515_fc814ccb-7f9d-45c8-bb75-80ca07e297ae.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-020-607161000206090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-020-60) 2017-12-140000-00-00NoNoCurrent