FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
71335-1821
11-digit product format
713351821
Labeler code
71335
Product ID
71335-1821_9796968c-599a-46d3-94e4-761b8a2db09c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209882
Marketing category
ANDA
Marketing start
2019-01-15
Marketing end
0000-00-00
Substance
METFORMIN HYDROCHLORIDE
Active strength
1000 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 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
08b3e508-8c7e-3b95-0275-113510642fc6Product name220220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8Product name120200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86Product name120200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5Product name120190731
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
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
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1821-02024-01-30C16284748780-11030e365-4ea1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995
71335-1821-12024-01-30C16284748780-11030e365-4ea1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995
71335-1821-22024-01-30C16284748780-11030e365-4ea1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995
71335-1821-32024-01-30C16284748780-11030e365-4ea1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995
71335-1821-42024-01-30C16284748780-11030e365-4ea1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995
71335-1821-52024-01-30C16284748780-11030e365-4ea1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995
71335-1821-62024-01-30C16284748780-11030e365-4ea1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995
71335-1821-72024-01-30C16284748780-11030e365-4ea1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995
71335-1821-82024-01-30C16284748780-11030e365-4ea1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1821-0Metformin Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED1000100
71335-1821-1Metformin Hydrochloride60 in 1 BOTTLETABLET, FILM COATED60100
71335-1821-2Metformin Hydrochloride100 in 1 BOTTLETABLET, FILM COATED100100
71335-1821-3Metformin Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30100
71335-1821-4Metformin Hydrochloride120 in 1 BOTTLETABLET, FILM COATED120100
71335-1821-5Metformin Hydrochloride90 in 1 BOTTLETABLET, FILM COATED90100
71335-1821-6Metformin Hydrochloride28 in 1 BOTTLETABLET, FILM COATED28100
71335-1821-7Metformin Hydrochloride56 in 1 BOTTLETABLET, FILM COATED56100
71335-1821-8Metformin Hydrochloride180 in 1 BOTTLETABLET, FILM COATED180100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1821METFORMIN HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]100Legacy NDC, 9 package rows20220107_2baa8521-f393-4608-adfa-a96e0660f6d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861004metFORMIN HCl 1000 MG Oral TabletPSN2baa8521-f393-4608-adfa-a96e0660f6d8100
861004metformin hydrochloride 1000 MG Oral TabletSCD2baa8521-f393-4608-adfa-a96e0660f6d8100
861004metformin HCl 1 GM Oral TabletSY2baa8521-f393-4608-adfa-a96e0660f6d8100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1821-0713351821001000 TABLET, FILM COATED in 1 BOTTLE (71335-1821-0) 2021-12-210000-00-00NoNoCurrent
71335-1821-17133518210160 TABLET, FILM COATED in 1 BOTTLE (71335-1821-1) 2021-12-210000-00-00NoNoCurrent
71335-1821-271335182102100 TABLET, FILM COATED in 1 BOTTLE (71335-1821-2) 2021-12-210000-00-00NoNoCurrent
71335-1821-37133518210330 TABLET, FILM COATED in 1 BOTTLE (71335-1821-3) 2021-12-210000-00-00NoNoCurrent
71335-1821-471335182104120 TABLET, FILM COATED in 1 BOTTLE (71335-1821-4) 2021-12-210000-00-00NoNoCurrent
71335-1821-57133518210590 TABLET, FILM COATED in 1 BOTTLE (71335-1821-5) 2021-12-210000-00-00NoNoCurrent
71335-1821-67133518210628 TABLET, FILM COATED in 1 BOTTLE (71335-1821-6) 2021-12-210000-00-00NoNoCurrent
71335-1821-77133518210756 TABLET, FILM COATED in 1 BOTTLE (71335-1821-7) 2021-12-210000-00-00NoNoCurrent
71335-1821-871335182108180 TABLET, FILM COATED in 1 BOTTLE (71335-1821-8) 2021-12-210000-00-00NoNoCurrent