FDA.reportPublic FDA data

METFORMIN HYDROCHLORIDE

Product NDC
72789-400
11-digit product format
727890400
Labeler code
72789
Product ID
72789-400_3cf82ef5-5b60-2c45-e063-6394a90a5d62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metformin hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA201991
Marketing category
ANDA
Marketing start
2013-03-01
Substance
METFORMIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
METFORMIN HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METFORMIN HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii786Z46389E
Rxcui860975

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6a29d87d-f465-752d-5fa9-bd728c608ca2Product name420251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698eProduct name120250724
a985afd1-89a8-bfab-0231-b59db1a3a9b5Product name720250515
25bfaa4d-02a1-402c-96ec-9bf6e625484cProduct name120250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0Product name220240829
16dbe107-66d5-47b3-57ed-0cba6a8dfcccProduct name620240215
08b3e508-8c7e-3b95-0275-113510642fc6Product name220220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8Product name120200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86Product name120200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5Product name120190731
ca3f036c-6c06-b829-b379-1a3a4097099cProduct name920180605
e1ede89f-54c8-428f-ae84-9e8a2deb67dbProduct name120180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52cProduct name220170824
bea938a6-c880-985b-d27b-b59b0d8b5a77Product name320170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2fProduct name120170616
e2382c7e-9e14-4196-aeff-98e2cfaf63cbProduct name120170224
988f737f-e7e9-4613-8558-824b1ab755f9Product name120161128
58b66776-50d5-434f-916f-958ccf131e0eProduct name120160713
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
2988466d-5fc4-4430-9cee-fc9132f02d2cProduct name120150910
85cbb42f-1a8d-f945-f85e-188e823b7f5bProduct name220150731
e740bf83-275a-4f0c-adf4-ec60ebd882b7Product name120150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0Product name120141205
0d79b284-47e8-e90c-f249-892b9b251003Product name120140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6Product name120140508
2de6e143-c970-2061-1b77-61c3aa8f4026Product name120140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776aProduct name120140508
ce63c1f8-ba50-8a17-9290-94522d75daffProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72789-400-01METFORMIN HYDROCHLORIDE100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE10014
72789-400-60METFORMIN HYDROCHLORIDE60 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE6014
72789-400-82METFORMIN HYDROCHLORIDE500 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE50014
72789-400-86METFORMIN HYDROCHLORIDE360 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE36014
72789-400-90METFORMIN HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE9014
72789-400-93METFORMIN HYDROCHLORIDE180 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE18014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-400-01EA - Each72789-400a6a3ddb2-8d28-4976-9ed2-bd8aafebd94a12025-02-10
72789-400-60EA - Each72789-4001dbfda39-cf27-4142-8d50-37ef3e4cf1d412024-07-12
72789-400-82EA - Each72789-40024083d02-a2f4-4a61-be90-b470b040d75512024-07-12
72789-400-86EA - Each72789-4003392c6e6-4894-4ca3-b83d-e1c8db11da5712024-06-10
72789-400-90EA - Each72789-40075836731-2edf-405f-9fba-a8ee5a4133cf12024-06-10
72789-400-93EA - Each72789-400b88a90ea-d207-4f7f-9e99-726ec99b95c412024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-400METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]12Current NDC, 6 package rows20250116_9171d369-d35a-40e4-a9ad-26484e66fc5e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN9171d369-d35a-40e4-a9ad-26484e66fc5e14
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD9171d369-d35a-40e4-a9ad-26484e66fc5e14
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY9171d369-d35a-40e4-a9ad-26484e66fc5e14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-400-0172789040001100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-400-01) 2025-01-15NoNoCurrent
72789-400-607278904006060 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-400-60) 2024-06-03NoNoCurrent
72789-400-8272789040082500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-400-82) 2024-06-03NoNoCurrent
72789-400-8672789040086360 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-400-86) 2024-05-17NoNoCurrent
72789-400-907278904009090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-400-90) 2024-05-17NoNoCurrent
72789-400-9372789040093180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-400-93) 2024-05-17NoNoCurrent