FDA.reportPublic FDA data

metformin hydrochloride

Product NDC
23155-103
11-digit product format
231550103
Labeler code
23155
Product ID
23155-103_e8946484-cf5a-7448-e053-2995a90a2acc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metformin hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc.
Application
ANDA090564
Marketing category
ANDA
Marketing start
2010-04-22
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
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
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-103-01EA - Each23155-103e9c32dd1-904d-40a6-8efc-c036bbbb3b0d12012-07-24
23155-103-05EA - Each23155-103b8b747c0-51a9-44ac-981e-8ab2122bffbb12012-07-24
23155-103-06EA - Each23155-1033bfdd38e-71cf-4eae-af25-41519eb7800e12015-12-02
23155-103-09EA - Each23155-10364f52abb-73a2-4e6f-b9d7-f84fe2ee215b12019-04-11
23155-103-10EA - Each23155-103fecba7e8-2e8d-473d-a3a0-caec0ab853b512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL INC.]3
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL INC.]3
BLACKBERRYINACTIVE INGREDIENT8A6OMU3I8LMETFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL INC.]3
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL INC.]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL INC.]3
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMETFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL INC.]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMETFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL INC.]3
POVIDONE K30INACTIVE INGREDIENTU725QWY32XMETFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL INC.]3
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZMETFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL INC.]3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861004metFORMIN HCl 1000 MG Oral TabletPSNbf6b3206-52ce-40d5-bc6d-a265effb7b2615
861007metFORMIN HCl 500 MG Oral TabletPSNbf6b3206-52ce-40d5-bc6d-a265effb7b2615
861010metFORMIN HCl 850 MG Oral TabletPSNbf6b3206-52ce-40d5-bc6d-a265effb7b2615
861004metformin hydrochloride 1000 MG Oral TabletSCDbf6b3206-52ce-40d5-bc6d-a265effb7b2615
861007metformin hydrochloride 500 MG Oral TabletSCDbf6b3206-52ce-40d5-bc6d-a265effb7b2615
861010metformin hydrochloride 850 MG Oral TabletSCDbf6b3206-52ce-40d5-bc6d-a265effb7b2615
861004metformin HCl 1 GM Oral TabletSYbf6b3206-52ce-40d5-bc6d-a265effb7b2615
861004metFORMIN HCl 1000 MG Oral TabletPSN69517af8-ac74-48e6-add7-1ef22661a8f65
861007metFORMIN HCl 500 MG Oral TabletPSN69517af8-ac74-48e6-add7-1ef22661a8f65
861010metFORMIN HCl 850 MG Oral TabletPSN69517af8-ac74-48e6-add7-1ef22661a8f65
861004metformin hydrochloride 1000 MG Oral TabletSCD69517af8-ac74-48e6-add7-1ef22661a8f65
861007metformin hydrochloride 500 MG Oral TabletSCD69517af8-ac74-48e6-add7-1ef22661a8f65
861010metformin hydrochloride 850 MG Oral TabletSCD69517af8-ac74-48e6-add7-1ef22661a8f65
861004metformin HCl 1 GM Oral TabletSY69517af8-ac74-48e6-add7-1ef22661a8f65
861010metFORMIN HCl 850 MG Oral TabletPSN9145db22-ec84-6f79-e053-2a95a90aa8264
861010metformin hydrochloride 850 MG Oral TabletSCD9145db22-ec84-6f79-e053-2a95a90aa8264
861004metFORMIN HCl 1000 MG Oral TabletPSN59a485b1-8299-5d02-e053-2a91aa0a42e33
861004metFORMIN HCl 1000 MG Oral TabletPSN398c563d-2286-4d11-9004-73fc57230b0c3
861007metFORMIN HCl 500 MG Oral TabletPSN59a485b1-8299-5d02-e053-2a91aa0a42e33
861007metFORMIN HCl 500 MG Oral TabletPSN398c563d-2286-4d11-9004-73fc57230b0c3
861010metFORMIN HCl 850 MG Oral TabletPSN59a485b1-8299-5d02-e053-2a91aa0a42e33
861010metFORMIN HCl 850 MG Oral TabletPSN9143527d-8877-5021-e053-2995a90abfd53
861010metFORMIN HCl 850 MG Oral TabletPSN398c563d-2286-4d11-9004-73fc57230b0c3
861004metformin hydrochloride 1000 MG Oral TabletSCD59a485b1-8299-5d02-e053-2a91aa0a42e33
861004metformin hydrochloride 1000 MG Oral TabletSCD398c563d-2286-4d11-9004-73fc57230b0c3
861007metformin hydrochloride 500 MG Oral TabletSCD398c563d-2286-4d11-9004-73fc57230b0c3
861007metformin hydrochloride 500 MG Oral TabletSCD59a485b1-8299-5d02-e053-2a91aa0a42e33
861010metformin hydrochloride 850 MG Oral TabletSCD9143527d-8877-5021-e053-2995a90abfd53
861010metformin hydrochloride 850 MG Oral TabletSCD59a485b1-8299-5d02-e053-2a91aa0a42e33
861010metformin hydrochloride 850 MG Oral TabletSCD398c563d-2286-4d11-9004-73fc57230b0c3
861004metformin HCl 1 GM Oral TabletSY398c563d-2286-4d11-9004-73fc57230b0c3
861004metformin HCl 1 GM Oral TabletSY59a485b1-8299-5d02-e053-2a91aa0a42e33
861010metFORMIN HCl 850 MG Oral TabletPSN2b44622c-9501-0ab7-e054-00144ff8d46c1
861010metformin hydrochloride 850 MG Oral TabletSCD2b44622c-9501-0ab7-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-103-0123155010301100 TABLET in 1 BOTTLE (23155-103-01) 100 tablet2010-04-220000-00-00NoNoCurrent
23155-103-0523155010305500 TABLET in 1 BOTTLE (23155-103-05) 500 tablet2010-04-220000-00-00NoNoCurrent
23155-103-062315501030660 TABLET in 1 BOTTLE (23155-103-06) 60 tablet2010-04-220000-00-00NoNoCurrent
23155-103-092315501030990 TABLET in 1 BOTTLE (23155-103-09) 90 tablet2019-02-070000-00-00NoNoCurrent
23155-103-10231550103101000 TABLET in 1 BOTTLE (23155-103-10) 1000 tablet2010-04-220000-00-00NoNoCurrent