FDA.reportPublic FDA data

METFORMIN HYDROCHLORIDE

Product NDC
10135-823
11-digit product format
101350823
Labeler code
10135
Product ID
10135-823_3e9d939c-6815-c5db-e063-6394a90ac9c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METFORMIN HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Marlex Pharmaceuticals, Inc.
Application
ANDA202306
Marketing category
ANDA
Marketing start
2025-08-01
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, 860981

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
10135-823-05METFORMIN HYDROCHLORIDE500 in 1 BOTTLETABLET, EXTENDED RELEASE5002
10135-823-10METFORMIN HYDROCHLORIDE1000 in 1 BOTTLETABLET, EXTENDED RELEASE10002
10135-823-30METFORMIN HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE302
10135-823-32METFORMIN HYDROCHLORIDE180 in 1 BOTTLETABLET, EXTENDED RELEASE1802
10135-823-33METFORMIN HYDROCHLORIDE360 in 1 BOTTLETABLET, EXTENDED RELEASE3602
10135-823-60METFORMIN HYDROCHLORIDE60 in 1 BOTTLETABLET, EXTENDED RELEASE602
10135-823-62METFORMIN HYDROCHLORIDE120 in 1 BOTTLETABLET, EXTENDED RELEASE1202
10135-823-90METFORMIN HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-823-05EA - Each10135-823bd0962cc-4012-48ee-9ed2-cf766e92c32412025-10-14
10135-823-30EA - Each10135-8230d142492-0645-4795-9b9e-8ebbcd3f246b12025-10-14
10135-823-32EA - Each10135-823be0fcd9c-764c-4165-8a1f-617688e5fe6112025-10-14
10135-823-33EA - Each10135-823fac3fc8e-3fac-434b-a1ad-51f69232f31f12025-10-14
10135-823-60EA - Each10135-8235263911f-a91a-4c31-8cf8-95625694fb7612025-10-14
10135-823-62EA - Each10135-823391c8087-f617-4638-b98b-b232b1e1724712025-10-14
10135-823-90EA - Each10135-82383283ae1-2b45-4133-a4e1-3d06a8c3602512025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN3d6f397b-e909-bee9-e063-6294a90aba172
860981metFORMIN HCl 750 MG 24HR Extended Release Oral TabletPSN3d6f397b-e909-bee9-e063-6294a90aba172
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD3d6f397b-e909-bee9-e063-6294a90aba172
86098124 HR metformin hydrochloride 750 MG Extended Release Oral TabletSCD3d6f397b-e909-bee9-e063-6294a90aba172
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY3d6f397b-e909-bee9-e063-6294a90aba172
860981metformin HCl 750 MG 24 HR Extended Release Oral TabletSY3d6f397b-e909-bee9-e063-6294a90aba172

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
10135-823-0510135082305500 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-05) 2025-08-01NoNoHistorical
10135-823-10101350823101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-10) 2025-08-01NoNoHistorical
10135-823-301013508233030 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-30) 2025-08-01NoNoHistorical
10135-823-3210135082332180 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-32) 2025-08-01NoNoHistorical
10135-823-3310135082333360 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-33) 2025-08-01NoNoHistorical
10135-823-601013508236060 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-60) 2025-08-01NoNoHistorical
10135-823-6210135082362120 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-62) 2025-08-01NoNoHistorical
10135-823-901013508239090 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-90) 2025-08-01NoNoHistorical