Metformin Hydrochloride

Product NDC
68645-300
11-digit product format
686450300
Labeler code
68645
Product ID
68645-300_e660bc2f-d56b-e101-e053-2a95a90a8c18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Legacy Pharmaceutical Packaging, LLC
Application
ANDA077095
Marketing category
ANDA
Marketing start
2012-01-13
Marketing end
0000-00-00
Substance
METFORMIN HYDROCHLORIDE
Active strength
1000 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
68645-300-59EA - Each68645-3001ad8e97b-4a89-4725-9b10-8f919a01151f12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68645-300METFORMIN HYDROCHLORIDE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC]12Legacy NDC20241016_3814cfed-029f-4231-bba3-89b2b4e01392.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68645-300-596864503005960 TABLET, FILM COATED in 1 BOTTLE (68645-300-59) 2012-01-130000-00-00NoNoCurrent