Metformin Hydrochloride

Product NDC
0615-8415
11-digit product format
006158415
Labeler code
0615
Product ID
0615-8415_c701b0ca-8e20-44d1-8144-a4786eedb14e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA206145
Marketing category
ANDA
Marketing start
2018-10-27
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
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0615-8415-390061584153930 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8415-39) 2021-12-080000-00-00NoNoCurrent