Metformin Hydrochloride Oral Solution

Product NDC
52817-822
11-digit product format
528170822
Labeler code
52817
Product ID
52817-822_e711470b-ad0e-495d-94ae-04c283dfd493
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
TRUPHARMA, LLC
Application
ANDA211309
Marketing category
ANDA
Marketing start
2022-01-25
Marketing end
0000-00-00
Substance
METFORMIN HYDROCHLORIDE
Active strength
500 mg/5mL
Pharmacologic classes
Biguanide [EPC], Biguanides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52817-822-50528170822505 TRAY in 1 CASE (52817-822-50) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE5 tray2022-01-250000-00-00NoNoCurrent