Metformin Hydrochloride

Product NDC
50268-531
11-digit product format
502680531
Labeler code
50268
Product ID
50268-531_d5de17c4-1838-3b92-e053-2a95a90ab88b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
AvPAK
Application
ANDA078596
Marketing category
ANDA
Marketing start
2010-07-27
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
50268-531-11EA - Each50268-531877ddf1d-d61a-471a-b421-a010bf536aa612015-05-05
50268-531-15EA - Each50268-531cc194882-6d0f-42ec-b979-783a1e5f0cc812012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-531-155026805311550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-531-15) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-531-11) 50 blister pack2010-07-270000-00-00NoNoCurrent