FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
51224-007
11-digit product format
512240007
Labeler code
51224
Product ID
51224-007_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
2026-10-31
Substance
METFORMIN HYDROCHLORIDE
Active strength
500 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 HYDROCHLORIDE500 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
51224-007-50Metformin Hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE1009
51224-007-60Metformin Hydrochloride500 in 1 BOTTLETABLET, EXTENDED RELEASE5009
51224-007-70Metformin Hydrochloride1000 in 1 BOTTLETABLET, EXTENDED RELEASE10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51224-007-50EA - Each51224-007f8e98f10-0d52-48bf-8bca-a91faaafa9be12016-07-19
51224-007-60EA - Each51224-0079a881fef-67f9-49b5-9558-25db0baf208e12016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51224-007METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [TAGI PHARMA, INC.]9Current NDC, Legacy NDC, 3 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 TabletPSNde4a660b-172b-4c72-9e38-5634fd03cfa710
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
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYde4a660b-172b-4c72-9e38-5634fd03cfa710
860981metformin HCl 750 MG 24 HR Extended Release Oral TabletSYde4a660b-172b-4c72-9e38-5634fd03cfa710
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNdd0ee2bf-f658-42dc-976d-49af0b1f32b59
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN96b40564-d7d6-655b-e053-2a95a90a1f959
860981metFORMIN HCl 750 MG 24HR Extended Release Oral TabletPSNdd0ee2bf-f658-42dc-976d-49af0b1f32b59
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDdd0ee2bf-f658-42dc-976d-49af0b1f32b59
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD96b40564-d7d6-655b-e053-2a95a90a1f959
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
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY96b40564-d7d6-655b-e053-2a95a90a1f959
860981metformin HCl 750 MG 24 HR Extended Release Oral TabletSYdd0ee2bf-f658-42dc-976d-49af0b1f32b59
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNa84cf1a3-3820-cd1b-e053-2995a90acf458
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDa84cf1a3-3820-cd1b-e053-2995a90acf458
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYa84cf1a3-3820-cd1b-e053-2995a90acf458
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN14607665-093a-4f10-b1e6-f618e380408e5
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN70a765db-7cf2-2958-e053-2991aa0adcb55
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD70a765db-7cf2-2958-e053-2991aa0adcb55
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD14607665-093a-4f10-b1e6-f618e380408e5
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY70a765db-7cf2-2958-e053-2991aa0adcb55
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY14607665-093a-4f10-b1e6-f618e380408e5
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNd80aa4af-a8ce-4cae-b71c-05e1de8295514
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDd80aa4af-a8ce-4cae-b71c-05e1de8295514
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYd80aa4af-a8ce-4cae-b71c-05e1de8295514
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNa9dd42c0-8f4a-4254-a1bd-9c298060cb982
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN4d89a4ab-6cdd-4c39-92f9-a137fa27a0702
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNfc61bafa-a506-14ae-e053-6394a90a9c7d2
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDa9dd42c0-8f4a-4254-a1bd-9c298060cb982
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD4d89a4ab-6cdd-4c39-92f9-a137fa27a0702
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDfc61bafa-a506-14ae-e053-6394a90a9c7d2
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYa9dd42c0-8f4a-4254-a1bd-9c298060cb982
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY4d89a4ab-6cdd-4c39-92f9-a137fa27a0702
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYfc61bafa-a506-14ae-e053-6394a90a9c7d2
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNceb4546d-2576-4b26-a5e5-120744f3c3dd1
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNe9cd0d23-56eb-40dd-abf4-9e681ec220f51
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDceb4546d-2576-4b26-a5e5-120744f3c3dd1
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDe9cd0d23-56eb-40dd-abf4-9e681ec220f51
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYceb4546d-2576-4b26-a5e5-120744f3c3dd1
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYe9cd0d23-56eb-40dd-abf4-9e681ec220f51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51224-007-5051224000750100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51224-007-50) 2016-06-012026-10-31NoNoCurrent
51224-007-6051224000760500 TABLET, EXTENDED RELEASE in 1 BOTTLE (51224-007-60) 2016-06-012026-10-31NoNoCurrent
51224-007-70512240007701000 TABLET, EXTENDED RELEASE in 1 BOTTLE (51224-007-70) 2019-01-012026-10-31NoNoCurrent