FDA.reportPublic FDA data

METFORMIN HYDROCHLORIDE

Product NDC
71335-0886
11-digit product format
713350886
Labeler code
71335
Product ID
71335-0886_f6130cb6-f4ba-47c1-bfe1-a9089ef4d524
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metformin hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0886-12025-08-25C16284748780-11030e365-1222-111a-e063-dadaa90a10e2These 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
71335-0886-22025-08-25C16284748780-11030e365-1222-111a-e063-dadaa90a10e2These 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
71335-0886-32025-08-25C16284748780-11030e365-1222-111a-e063-dadaa90a10e2These 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
71335-0886-42025-08-25C16284748780-11030e365-1222-111a-e063-dadaa90a10e2These 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
71335-0886-52025-08-25C16284748780-11030e365-1222-111a-e063-dadaa90a10e2These 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
71335-0886-62025-08-25C16284748780-11030e365-1222-111a-e063-dadaa90a10e2These 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
71335-0886-72025-08-25C16284748780-11030e365-1222-111a-e063-dadaa90a10e2These 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
71335-0886-82025-08-25C16284748780-11030e365-1222-111a-e063-dadaa90a10e2These 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
71335-0886-92025-08-25C16284748780-11030e365-1222-111a-e063-dadaa90a10e2These 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
71335-0886-12024-01-30C16284748780-11030e365-1222-111a-e063-dadaa90a10e2These 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
71335-0886-22024-01-30C16284748780-11030e365-1222-111a-e063-dadaa90a10e2These 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
71335-0886-32024-01-30C16284748780-11030e365-1222-111a-e063-dadaa90a10e2These 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
71335-0886-42024-01-30C16284748780-11030e365-1222-111a-e063-dadaa90a10e2These 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
71335-0886-52024-01-30C16284748780-11030e365-1222-111a-e063-dadaa90a10e2These 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
71335-0886-62024-01-30C16284748780-11030e365-1222-111a-e063-dadaa90a10e2These 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
71335-0886-72024-01-30C16284748780-11030e365-1222-111a-e063-dadaa90a10e2These 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
71335-0886-82024-01-30C16284748780-11030e365-1222-111a-e063-dadaa90a10e2These 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
71335-0886-92024-01-30C16284748780-11030e365-1222-111a-e063-dadaa90a10e2These 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
71335-0886-1METFORMIN HYDROCHLORIDE60 in 1 BOTTLETABLET, EXTENDED RELEASE605
71335-0886-2METFORMIN HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE305
71335-0886-3METFORMIN HYDROCHLORIDE100 in 1 BOTTLETABLET, EXTENDED RELEASE1005
71335-0886-4METFORMIN HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE905
71335-0886-5METFORMIN HYDROCHLORIDE120 in 1 BOTTLETABLET, EXTENDED RELEASE1205
71335-0886-6METFORMIN HYDROCHLORIDE15 in 1 BOTTLETABLET, EXTENDED RELEASE155
71335-0886-7METFORMIN HYDROCHLORIDE45 in 1 BOTTLETABLET, EXTENDED RELEASE455
71335-0886-8METFORMIN HYDROCHLORIDE180 in 1 BOTTLETABLET, EXTENDED RELEASE1805
71335-0886-9METFORMIN HYDROCHLORIDE20 in 1 BOTTLETABLET, EXTENDED RELEASE205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0886METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 9 package rows20220202_f2318509-9a49-4c99-a08b-22381f17aacd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNf2318509-9a49-4c99-a08b-22381f17aacd5
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDf2318509-9a49-4c99-a08b-22381f17aacd5
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYf2318509-9a49-4c99-a08b-22381f17aacd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0886-17133508860160 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0886-1) 2018-08-200000-00-00NoNoCurrent
71335-0886-27133508860230 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0886-2) 2021-12-270000-00-00NoNoCurrent
71335-0886-371335088603100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0886-3) 2018-07-170000-00-00NoNoCurrent
71335-0886-47133508860490 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0886-4) 2018-08-070000-00-00NoNoCurrent
71335-0886-571335088605120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0886-5) 2018-06-280000-00-00NoNoCurrent
71335-0886-67133508860615 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0886-6) 2021-12-270000-00-00NoNoCurrent
71335-0886-77133508860745 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0886-7) 2021-12-270000-00-00NoNoCurrent
71335-0886-871335088608180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0886-8) 2021-12-270000-00-00NoNoCurrent
71335-0886-97133508860920 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0886-9) 2021-12-270000-00-00NoNoCurrent