FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
53746-178
11-digit product format
537460178
Labeler code
53746
Product ID
53746-178_c6b18bc5-6548-4986-b6fc-a5f1958d5074
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA078596
Marketing category
ANDA
Marketing start
2009-12-02
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
2022-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53746-178-012023-01-30C16284748780-1ba0f9c33-3072-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS . METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
53746-178-052023-01-30C16284748780-1ba0f9c33-3072-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS . METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
53746-178-102023-01-30C16284748780-1ba0f9c33-3072-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS . METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
53746-178-302023-01-30C16284748780-1ba0f9c33-3072-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS . METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
53746-178-902023-01-30C16284748780-1ba0f9c33-3072-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS . METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
53746-178-012021-03-18C16284748780-1ba0f9c33-3072-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS . METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
53746-178-052021-03-18C16284748780-1ba0f9c33-3072-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS . METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
53746-178-102021-03-18C16284748780-1ba0f9c33-3072-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS . METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
53746-178-302021-03-18C16284748780-1ba0f9c33-3072-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS . METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
53746-178-902021-03-18C16284748780-1ba0f9c33-3072-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS . METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
53746-178-012021-01-29C16284748780-1ba0f9c33-3072-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS . METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
53746-178-052021-01-29C16284748780-1ba0f9c33-3072-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS . METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
53746-178-102021-01-29C16284748780-1ba0f9c33-3072-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS . METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
53746-178-302021-01-29C16284748780-1ba0f9c33-3072-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS . METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
53746-178-902021-01-29C16284748780-1ba0f9c33-3072-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS . METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53746-178-01Metformin Hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE10014
53746-178-05Metformin Hydrochloride500 in 1 BOTTLETABLET, EXTENDED RELEASE50014
53746-178-10Metformin Hydrochloride1000 in 1 BOTTLETABLET, EXTENDED RELEASE100014
53746-178-30Metformin Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE3014
53746-178-90Metformin Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-178-01EA - Each53746-17835b51129-1095-47d8-8b1d-c5db2faf273712012-07-24
53746-178-05EA - Each53746-1782e7c0331-51cb-4744-b0b1-c43ae50524e712012-07-24
53746-178-10EA - Each53746-17809cfd689-47f5-4f78-9550-e8469425acf612012-07-24
53746-178-90EA - Each53746-1783f714040-1975-48b3-85ff-deaafa3a1fa212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]2
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-178METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]14Legacy NDC, 5 package rows20210319_ee2739df-8db4-4b05-9a81-1590efbb589b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNee2739df-8db4-4b05-9a81-1590efbb589b14
860981metFORMIN HCl 750 MG 24HR Extended Release Oral TabletPSNee2739df-8db4-4b05-9a81-1590efbb589b14
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDee2739df-8db4-4b05-9a81-1590efbb589b14
86098124 HR metformin hydrochloride 750 MG Extended Release Oral TabletSCDee2739df-8db4-4b05-9a81-1590efbb589b14
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYee2739df-8db4-4b05-9a81-1590efbb589b14
860981metformin HCl 750 MG 24 HR Extended Release Oral TabletSYee2739df-8db4-4b05-9a81-1590efbb589b14
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN54c8b06e-13d2-43d3-8405-f43719b7ead93
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD54c8b06e-13d2-43d3-8405-f43719b7ead93
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY54c8b06e-13d2-43d3-8405-f43719b7ead93
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN4b163d1c-0bd6-4002-a954-b1b2cc8325bc2
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD4b163d1c-0bd6-4002-a954-b1b2cc8325bc2
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY4b163d1c-0bd6-4002-a954-b1b2cc8325bc2
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN3de79b9f-6dc9-400f-b44e-c12921ac824b1
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD3de79b9f-6dc9-400f-b44e-c12921ac824b1
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY3de79b9f-6dc9-400f-b44e-c12921ac824b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53746-178-0153746017801100 TABLET, EXTENDED RELEASE in 1 BOTTLE (53746-178-01) 2009-12-020000-00-00NoNoCurrent
53746-178-0553746017805500 TABLET, EXTENDED RELEASE in 1 BOTTLE (53746-178-05) 2009-12-020000-00-00NoNoCurrent
53746-178-10537460178101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (53746-178-10) 2009-12-020000-00-00NoNoCurrent
53746-178-305374601783030 TABLET, EXTENDED RELEASE in 1 BOTTLE (53746-178-30) 2009-12-020000-00-00NoNoCurrent
53746-178-905374601789090 TABLET, EXTENDED RELEASE in 1 BOTTLE (53746-178-90) 2009-12-020000-00-00NoNoCurrent