Metformin Hydrochloride

Product NDC
63629-8166
11-digit product format
636298166
Labeler code
63629
Product ID
63629-8166_cbdc435b-9a9e-4fad-a11a-d2aa81076ad2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078321
Marketing category
ANDA
Marketing start
2008-04-17
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

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8166-163629816601180 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8166-1) 2019-07-290000-00-00NoNoCurrent
63629-8166-26362981660230 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8166-2) 2019-07-290000-00-00NoNoCurrent