FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
51224-107
11-digit product format
512240107
Labeler code
51224
Product ID
51224-107_edb2d11c-e64f-4f34-9f13-98b4f9a834a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
TAGI Pharma, Inc.
Application
ANDA078321
Marketing category
ANDA
Marketing start
2008-04-17
Marketing end
2026-11-30
Substance
METFORMIN HYDROCHLORIDE
Active strength
750 mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metformin Hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METFORMIN HYDROCHLORIDE750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii786Z46389E
Rxcui860975, 860981

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51224-107-50Metformin Hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE1009
51224-107-60Metformin Hydrochloride500 in 1 BOTTLETABLET, EXTENDED RELEASE5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51224-107-50EA - Each51224-10754e4d5a7-34d2-4a83-b0ec-4122119693bb12016-07-19
51224-107-60EA - Each51224-10796545bc2-a4b8-4b4a-bb01-abc616e4437012016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51224-107METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [TAGI PHARMA, INC.]9Current NDC, Legacy NDC, 2 package rows20250424_dd0ee2bf-f658-42dc-976d-49af0b1f32b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNde4a660b-172b-4c72-9e38-5634fd03cfa710
860981metFORMIN HCl 750 MG 24HR Extended Release Oral TabletPSN1503bbe4-0ac5-479b-9900-d38e49236bf010
860981metFORMIN HCl 750 MG 24HR Extended Release Oral TabletPSNde4a660b-172b-4c72-9e38-5634fd03cfa710
860981metFORMIN HCl 750 MG 24HR Extended Release Oral TabletPSN87addc6d-32c5-4b6d-90f2-7c7dbcfdc29c10
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDde4a660b-172b-4c72-9e38-5634fd03cfa710
86098124 HR metformin hydrochloride 750 MG Extended Release Oral TabletSCDde4a660b-172b-4c72-9e38-5634fd03cfa710
86098124 HR metformin hydrochloride 750 MG Extended Release Oral TabletSCD1503bbe4-0ac5-479b-9900-d38e49236bf010
86098124 HR metformin hydrochloride 750 MG Extended Release Oral TabletSCD87addc6d-32c5-4b6d-90f2-7c7dbcfdc29c10
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYde4a660b-172b-4c72-9e38-5634fd03cfa710
860981metformin HCl 750 MG 24 HR Extended Release Oral TabletSY1503bbe4-0ac5-479b-9900-d38e49236bf010
860981metformin HCl 750 MG 24 HR Extended Release Oral TabletSYde4a660b-172b-4c72-9e38-5634fd03cfa710
860981metformin HCl 750 MG 24 HR Extended Release Oral TabletSY87addc6d-32c5-4b6d-90f2-7c7dbcfdc29c10
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNdd0ee2bf-f658-42dc-976d-49af0b1f32b59
860981metFORMIN HCl 750 MG 24HR Extended Release Oral TabletPSNdd0ee2bf-f658-42dc-976d-49af0b1f32b59
860981metFORMIN HCl 750 MG 24HR Extended Release Oral TabletPSNbf918d78-3fb6-4d8d-b42d-538ea10bc3e49
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDdd0ee2bf-f658-42dc-976d-49af0b1f32b59
86098124 HR metformin hydrochloride 750 MG Extended Release Oral TabletSCDbf918d78-3fb6-4d8d-b42d-538ea10bc3e49
86098124 HR metformin hydrochloride 750 MG Extended Release Oral TabletSCDdd0ee2bf-f658-42dc-976d-49af0b1f32b59
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYdd0ee2bf-f658-42dc-976d-49af0b1f32b59
860981metformin HCl 750 MG 24 HR Extended Release Oral TabletSYbf918d78-3fb6-4d8d-b42d-538ea10bc3e49
860981metformin HCl 750 MG 24 HR Extended Release Oral TabletSYdd0ee2bf-f658-42dc-976d-49af0b1f32b59
860981metFORMIN HCl 750 MG 24HR Extended Release Oral TabletPSNab80521b-5014-cc2a-e053-2a95a90a20034
860981metFORMIN HCl 750 MG 24HR Extended Release Oral TabletPSN692dc5fe-bdc8-f0eb-e053-2a91aa0a85ad4
86098124 HR metformin hydrochloride 750 MG Extended Release Oral TabletSCDab80521b-5014-cc2a-e053-2a95a90a20034
86098124 HR metformin hydrochloride 750 MG Extended Release Oral TabletSCD692dc5fe-bdc8-f0eb-e053-2a91aa0a85ad4
860981metformin HCl 750 MG 24 HR Extended Release Oral TabletSYab80521b-5014-cc2a-e053-2a95a90a20034
860981metformin HCl 750 MG 24 HR Extended Release Oral TabletSY692dc5fe-bdc8-f0eb-e053-2a91aa0a85ad4
860981metFORMIN HCl 750 MG 24HR Extended Release Oral TabletPSN6f6118c1-cecc-4d7b-9965-7b114a1ad56b3
860981metFORMIN HCl 750 MG 24HR Extended Release Oral TabletPSN737e5f81-3d75-2eb6-e053-2991aa0a5c693
86098124 HR metformin hydrochloride 750 MG Extended Release Oral TabletSCD6f6118c1-cecc-4d7b-9965-7b114a1ad56b3
86098124 HR metformin hydrochloride 750 MG Extended Release Oral TabletSCD737e5f81-3d75-2eb6-e053-2991aa0a5c693
860981metformin HCl 750 MG 24 HR Extended Release Oral TabletSY6f6118c1-cecc-4d7b-9965-7b114a1ad56b3
860981metformin HCl 750 MG 24 HR Extended Release Oral TabletSY737e5f81-3d75-2eb6-e053-2991aa0a5c693

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51224-107-5051224010750100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51224-107-50) 2016-06-012026-11-30NoNoCurrent
51224-107-6051224010760500 TABLET, EXTENDED RELEASE in 1 BOTTLE (51224-107-60) 2016-06-012026-11-30NoNoCurrent