Metformin Hydrochloride

Product NDC
72789-059
11-digit product format
727890059
Labeler code
72789
Product ID
72789-059_e725dbb0-9483-55d0-e053-2a95a90ad01d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-059-30EA - Each72789-05963ccdd5e-1a5f-4f2e-8603-a4b03bfd259212020-07-13
72789-059-60EA - Each72789-05904ab1455-27bb-4c46-9aa5-a441c46ae9c312020-04-20
72789-059-90EA - Each72789-0596ba25511-287a-4d34-9fd4-389fffb3d44312020-04-20
72789-059-93EA - Each72789-0591c933c34-074e-4daf-9afa-0fbb7d3c44ba12020-07-13
72789-059-98EA - Each72789-059d6a1b3ae-53c6-47b7-ba1f-93603b91a21912022-10-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-059-307278900593030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-059-30) 2020-05-270000-00-00NoNoCurrent
72789-059-607278900596060 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-059-60) 2020-03-020000-00-00NoNoCurrent
72789-059-907278900599090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-059-90) 2020-03-020000-00-00NoNoCurrent
72789-059-9372789005993180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-059-93) 2020-05-050000-00-00NoNoCurrent
72789-059-9872789005998120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-059-98) 2022-08-260000-00-00NoNoCurrent