FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
43353-811
11-digit product format
433530811
Labeler code
43353
Product ID
43353-811_a1f2eedc-8ca8-46a4-b87f-1a976103e933
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077880
Marketing category
ANDA
Marketing start
2012-06-26
Marketing end
0000-00-00
Substance
METFORMIN HYDROCHLORIDE
Active strength
850 mg/1
Pharmacologic classes
Biguanide [EPC],Biguanides [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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
43353-811-302020-01-31C16284748780-19d75b9d0-1708-f424-e053-dadaa90a57ceMetformin Hydrochloride Tablets, USP
43353-811-532020-01-31C16284748780-19d75b9d0-1708-f424-e053-dadaa90a57ceMetformin Hydrochloride Tablets, USP
43353-811-602020-01-31C16284748780-19d75b9d0-1708-f424-e053-dadaa90a57ceMetformin Hydrochloride Tablets, USP
43353-811-802020-01-31C16284748780-19d75b9d0-1708-f424-e053-dadaa90a57ceMetformin Hydrochloride Tablets, USP
43353-811-922020-01-31C16284748780-19d75b9d0-1708-f424-e053-dadaa90a57ceMetformin Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-811-30Metformin Hydrochloride30 in 1 BOTTLE, PLASTICTABLET302
43353-811-53Metformin Hydrochloride60 in 1 BOTTLE, PLASTICTABLET602
43353-811-60Metformin Hydrochloride90 in 1 BOTTLE, PLASTICTABLET902
43353-811-80Metformin Hydrochloride180 in 1 BOTTLE, PLASTICTABLET1802
43353-811-92Metformin Hydrochloride270 in 1 BOTTLE, PLASTICTABLET2702

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-811-53EA - Each43353-811369d4b69-2312-4655-a5c1-335353cb9ba412014-06-03
43353-811-60EA - Each43353-81173555096-6c3a-4be7-ab0b-00ede1cd11d912018-01-12
43353-811-80EA - Each43353-811c6e26303-b2e4-4f0f-8dfb-47645026dabb12018-01-12
43353-811-92EA - Each43353-8116e8c9ea6-6cd7-49cc-b98d-905659d8ded612018-01-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
AcaciaINACTIVE INGREDIENT5C5403N26OMETFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UMETFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MaltodextrinINACTIVE INGREDIENT7CVR7L4A2DMETFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1AMETFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
Polyvinyl AlcoholINACTIVE INGREDIENT532B59J990METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
PovidoneINACTIVE INGREDIENTFZ989GH94EMETFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TalcINACTIVE INGREDIENT7SEV7J4R1UMETFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPMETFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-811METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 5 package rows20171214_789e5537-5b4a-40f3-bd4f-5270432dc169.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861004metFORMIN HCl 1000 MG Oral TabletPSN789e5537-5b4a-40f3-bd4f-5270432dc1692
861007metFORMIN HCl 500 MG Oral TabletPSN789e5537-5b4a-40f3-bd4f-5270432dc1692
861010metFORMIN HCl 850 MG Oral TabletPSN789e5537-5b4a-40f3-bd4f-5270432dc1692
861004metformin hydrochloride 1000 MG Oral TabletSCD789e5537-5b4a-40f3-bd4f-5270432dc1692
861007metformin hydrochloride 500 MG Oral TabletSCD789e5537-5b4a-40f3-bd4f-5270432dc1692
861010metformin hydrochloride 850 MG Oral TabletSCD789e5537-5b4a-40f3-bd4f-5270432dc1692
861004metformin HCl 1 GM Oral TabletSY789e5537-5b4a-40f3-bd4f-5270432dc1692

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-811-304335308113030 in 1 BOTTLE, PLASTICHistorical
43353-811-534335308115360 in 1 BOTTLE, PLASTICHistorical
43353-811-604335308116090 in 1 BOTTLE, PLASTICHistorical
43353-811-8043353081180180 in 1 BOTTLE, PLASTICHistorical
43353-811-9243353081192270 in 1 BOTTLE, PLASTICHistorical