Metformin Hydrochloride Oral Solution

Product NDC
63629-2501
11-digit product format
636292501
Labeler code
63629
Product ID
63629-2501_3698fb5c-94ad-4b01-8067-427e33188a93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211309
Marketing category
ANDA
Marketing start
2020-04-20
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2501-1ML - Milliliter63629-2501dcbc9ae2-396c-4798-8174-3b165e56901412021-04-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2501-163629250101473 mL in 1 BOTTLE (63629-2501-1) 473 ml2021-03-010000-00-00NoNoCurrent