Metformin Hydrochloride

Product NDC
42291-610
11-digit product format
422910610
Labeler code
42291
Product ID
42291-610_d7fd7dc0-4556-be92-e053-2995a90ab022
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
AvKARE
Application
ANDA078596
Marketing category
ANDA
Marketing start
2010-10-04
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
42291-610-01EA - Each42291-610de734936-68a4-42a6-8648-3ea20bd5e23f12020-03-10
42291-610-10EA - Each42291-61011fe126d-ba85-4492-abf0-dfe805bead8412013-08-02
42291-610-18EA - Each42291-6101a2c96cb-8a78-401c-a065-c7f7eafcff4312012-07-24
42291-610-36EA - Each42291-610f034fdf9-f513-46c8-9e30-30cb1326a3f612012-07-24
42291-610-90EA - Each42291-610dfb0d8fa-3616-4979-bc69-c676cc9433df12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-610-0142291061001100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-610-01) 2019-10-310000-00-00NoNoCurrent
42291-610-10422910610101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-610-10) 2013-06-190000-00-00NoNoCurrent
42291-610-1842291061018180 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-610-18) 2010-10-040000-00-00NoNoCurrent
42291-610-3642291061036360 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-610-36) 2010-10-040000-00-00NoNoCurrent
42291-610-904229106109090 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-610-90) 2010-10-040000-00-00NoNoCurrent