FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
50090-3719
11-digit product format
500903719
Labeler code
50090
Product ID
50090-3719_2fdc403b-eb7a-473a-926f-1b2fa1b5b9cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078321
Marketing category
ANDA
Marketing start
2008-04-17
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
50090-3719-02023-01-30C16284748780-1f386c64a-28af-0266-e053-dadaa90a7c1aThese 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
50090-3719-12023-01-30C16284748780-1f386c64a-28af-0266-e053-dadaa90a7c1aThese 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
50090-3719-22023-01-30C16284748780-1f386c64a-28af-0266-e053-dadaa90a7c1aThese 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
50090-3719-32023-01-30C16284748780-1f386c64a-28af-0266-e053-dadaa90a7c1aThese 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
50090-3719-0Metformin Hydrochloride60 in 1 BOTTLETABLET, EXTENDED RELEASE605
50090-3719-1Metformin Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE305
50090-3719-2Metformin Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE905
50090-3719-3Metformin Hydrochloride180 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3719METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]5Legacy NDC, 4 package rows20210417_14607665-093a-4f10-b1e6-f618e380408e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN14607665-093a-4f10-b1e6-f618e380408e5
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD14607665-093a-4f10-b1e6-f618e380408e5
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY14607665-093a-4f10-b1e6-f618e380408e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3719-05009037190060 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-3719-0) 2018-10-240000-00-00NoNoCurrent
50090-3719-15009037190130 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-3719-1) 2014-11-280000-00-00NoNoCurrent
50090-3719-25009037190290 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-3719-2) 2014-11-280000-00-00NoNoCurrent
50090-3719-350090371903180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-3719-3) 2014-11-280000-00-00NoNoCurrent