FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
53746-218
11-digit product format
537460218
Labeler code
53746
Product ID
53746-218_87735a77-fc44-4fb2-b8f4-1dc44d13ad0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA077880
Marketing category
ANDA
Marketing start
2012-12-17
Substance
METFORMIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metformin Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METFORMIN HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii786Z46389E
Rxcui861004, 861007, 861010

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
53746-218-01Metformin Hydrochloride100 in 1 BOTTLETABLET10013
53746-218-05Metformin Hydrochloride500 in 1 BOTTLETABLET50013
53746-218-10Metformin Hydrochloride1000 in 1 BOTTLETABLET100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-218-01EA - Each53746-218c40a4e21-4390-49c6-ab75-d73bd5db00e612013-12-02
53746-218-05EA - Each53746-21843749a15-70aa-4d2f-a6bd-91bbca40377612013-12-02
53746-218-10EA - Each53746-2187b3a1400-b635-44f3-9c91-f8c0e0d61d9d12013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]9
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]9
ACACIAINACTIVE INGREDIENT5C5403N26OMETFORMIN HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]9
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMETFORMIN HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]9
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3METFORMIN HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]9
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET [READYMEDS]6
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET [READYMEDS]6
ACACIAINACTIVE INGREDIENT5C5403N26OMETFORMIN HYDROCHLORIDE TABLET [READYMEDS]6
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMETFORMIN HYDROCHLORIDE TABLET [READYMEDS]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3METFORMIN HYDROCHLORIDE TABLET [READYMEDS]6
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
ACACIAINACTIVE INGREDIENT5C5403N26OMETFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMETFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3METFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-218METFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]13Current NDC, Legacy NDC, 3 package rows20240420_b090b18b-b53c-4c92-892f-d11551cfedc3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861007metFORMIN HCl 500 MG Oral TabletPSN0230a3c3-34cf-478b-88c3-4d96e530001819
861007metformin hydrochloride 500 MG Oral TabletSCD0230a3c3-34cf-478b-88c3-4d96e530001819
861004metFORMIN HCl 1000 MG Oral TabletPSNb090b18b-b53c-4c92-892f-d11551cfedc313
861007metFORMIN HCl 500 MG Oral TabletPSNb090b18b-b53c-4c92-892f-d11551cfedc313
861010metFORMIN HCl 850 MG Oral TabletPSNb090b18b-b53c-4c92-892f-d11551cfedc313
861004metformin hydrochloride 1000 MG Oral TabletSCDb090b18b-b53c-4c92-892f-d11551cfedc313
861007metformin hydrochloride 500 MG Oral TabletSCDb090b18b-b53c-4c92-892f-d11551cfedc313
861010metformin hydrochloride 850 MG Oral TabletSCDb090b18b-b53c-4c92-892f-d11551cfedc313
861004metformin HCl 1 GM Oral TabletSYb090b18b-b53c-4c92-892f-d11551cfedc313
861007metFORMIN HCl 500 MG Oral TabletPSNf19ad89c-8dbe-4806-8068-f63aa895488d6
861007metformin hydrochloride 500 MG Oral TabletSCDf19ad89c-8dbe-4806-8068-f63aa895488d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-218-0153746021801100 TABLET in 1 BOTTLE (53746-218-01) 100 tablet2012-12-170000-00-00NoNoCurrent
53746-218-0553746021805500 TABLET in 1 BOTTLE (53746-218-05) 500 tablet2012-12-170000-00-00NoNoCurrent
53746-218-10537460218101000 TABLET in 1 BOTTLE (53746-218-10) 1000 tablet2012-12-170000-00-00NoNoCurrent