metformin hydrochloride

Product NDC
0185-4416
11-digit product format
001854416
Labeler code
0185
Product ID
0185-4416_e6950b9a-5011-479b-835b-6a6a3af93b9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metformin hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Eon Labs, Inc.
Application
ANDA076873
Marketing category
ANDA
Marketing start
2004-12-14
Marketing end
2021-07-31
Substance
METFORMIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Biguanide [EPC],Biguanides [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0185-4416-01EA - Each0185-4416c818289f-480b-41ea-ade0-497cc0ad6f4212012-07-24
0185-4416-05EA - Each0185-441625351e85-608a-4c77-894d-4c71f389a9e612012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0185-4416-0100185441601100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-4416-01) 2004-12-142021-07-31NoNoCurrent
0185-4416-0500185441605500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-4416-05) 2004-12-142021-07-31NoNoCurrent
0185-4416-7500185441675750 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-4416-75) 2004-12-142021-07-31NoNoCurrent