Metformin Hydrochloride

Product NDC
42291-559
11-digit product format
422910559
Labeler code
42291
Product ID
42291-559_d57d9fd8-82cf-3c89-e053-2995a90aa9f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
AvKARE
Application
ANDA203755
Marketing category
ANDA
Marketing start
2017-11-21
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
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
42291-559-90EA - Each42291-5595335fc88-89d0-41b2-8443-39d697cc135912018-01-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-559-904229105599090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-559-90) 2017-11-210000-00-00NoNoCurrent