FDA.reportPublic FDA data

metformin hydrochloride

Product NDC
42806-406
11-digit product format
428060406
Labeler code
42806
Product ID
42806-406_1edb3813-b7cb-4501-ad91-eae58624c836
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metformin hydrochloride tablet
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
EPIC PHARMA, LLC
Application
ANDA209993
Marketing category
ANDA
Marketing start
2019-01-04
Substance
METFORMIN HYDROCHLORIDE
Active strength
1000 mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
metformin hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METFORMIN HYDROCHLORIDE1000 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii786Z46389E
Rxcui1807894, 1807917

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
42806-406-602021-02-03C16284748780-1ba0f9c33-301b-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. Initial U.S. Approval: 1995
42806-406-602021-01-29C16284748780-1ba0f9c33-301b-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. Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-406-60metformin hydrochloride60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-406-60EA - Each42806-4066e3eb943-fd14-46a5-b918-26135c1daf7f12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-406METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE TABLETS) TABLET, FILM COATED, EXTENDED RELEASE METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE TABLET) TABLET, FILM COATED, EXTENDED RELEASE [EPIC PHARMA, LLC]4Current NDC, Legacy NDC, 1 package rows20241222_356b02d0-d239-4441-bb33-c4c54166fcd7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807894metFORMIN HCl 1000 MG Osmotic 24HR Extended Release Oral TabletPSN356b02d0-d239-4441-bb33-c4c54166fcd76
1807917metFORMIN HCl 500 MG Osmotic 24HR Extended Release Oral TabletPSN356b02d0-d239-4441-bb33-c4c54166fcd76
1807894Osmotic 24 HR metformin hydrochloride 1000 MG Extended Release Oral TabletSCD356b02d0-d239-4441-bb33-c4c54166fcd76
1807917Osmotic 24 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD356b02d0-d239-4441-bb33-c4c54166fcd76
1807894metformin HCl 1000 MG Osmotic 24 HR Extended Release Oral TabletSY356b02d0-d239-4441-bb33-c4c54166fcd76
1807917metformin HCl 500 MG Osmotic 24HR Extended Release Oral TabletSY356b02d0-d239-4441-bb33-c4c54166fcd76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42806-406-604280604066060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42806-406-60) 2019-01-040000-00-00NoNoCurrent