Metformin Hydrochloride

Product NDC
42291-558
11-digit product format
422910558
Labeler code
42291
Product ID
42291-558_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
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
42291-558-90EA - Each42291-5585f58b1ca-b743-4749-b630-98c4b9d79e0212018-01-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-558-904229105589090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-558-90) 2017-11-210000-00-00NoNoCurrent