FDA.reportPublic FDA data

METFORMIN HYDROCHLORIDE

Product NDC
62756-142
11-digit product format
627560142
Labeler code
62756
Product ID
62756-142_69a60382-bf12-4627-baaf-2e0ac332b443
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METFORMIN HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA077336
Marketing category
ANDA
Marketing start
2006-02-09
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

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
62756-142-01EA - Each62756-142521462cb-f68e-4843-b6e4-c09a4bbf4a4612012-07-24
62756-142-02EA - Each62756-142100d3d57-3c3c-4d4c-916b-f9436496cbbe12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED]5
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED]5
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED]5
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED]5
TALCINACTIVE INGREDIENT7SEV7J4R1UMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED]5
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED]5
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2
TALCINACTIVE INGREDIENT7SEV7J4R1UMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HCL ER (METFORMIN HYDROCHLORIDE EXTENDED RELEASE) TABLET [NORTHWIND PHARMACEUTICALS]1
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HCL ER (METFORMIN HYDROCHLORIDE EXTENDED RELEASE) TABLET [NORTHWIND PHARMACEUTICALS]1
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETFORMIN HCL ER (METFORMIN HYDROCHLORIDE EXTENDED RELEASE) TABLET [NORTHWIND PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HCL ER (METFORMIN HYDROCHLORIDE EXTENDED RELEASE) TABLET [NORTHWIND PHARMACEUTICALS]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETFORMIN HCL ER (METFORMIN HYDROCHLORIDE EXTENDED RELEASE) TABLET [NORTHWIND PHARMACEUTICALS]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METFORMIN HCL ER (METFORMIN HYDROCHLORIDE EXTENDED RELEASE) TABLET [NORTHWIND PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TMETFORMIN HCL ER (METFORMIN HYDROCHLORIDE EXTENDED RELEASE) TABLET [NORTHWIND PHARMACEUTICALS]1
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMETFORMIN HCL ER (METFORMIN HYDROCHLORIDE EXTENDED RELEASE) TABLET [NORTHWIND PHARMACEUTICALS]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEMETFORMIN HCL ER (METFORMIN HYDROCHLORIDE EXTENDED RELEASE) TABLET [NORTHWIND PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-142METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]9Current NDC, Legacy NDC20200904_41a8bb80-7b0b-476c-8134-5d161c3239c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN24cde2c2-dac7-4cdb-8329-c2f88ebd4f984
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN56cfd673-6594-5292-e054-00144ff8d46c4
860981metFORMIN HCl 750 MG 24HR Extended Release Oral TabletPSN24cde2c2-dac7-4cdb-8329-c2f88ebd4f984
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD24cde2c2-dac7-4cdb-8329-c2f88ebd4f984
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD56cfd673-6594-5292-e054-00144ff8d46c4
86098124 HR metformin hydrochloride 750 MG Extended Release Oral TabletSCD24cde2c2-dac7-4cdb-8329-c2f88ebd4f984
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY24cde2c2-dac7-4cdb-8329-c2f88ebd4f984
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY56cfd673-6594-5292-e054-00144ff8d46c4
860981metformin HCl 750 MG 24 HR Extended Release Oral TabletSY24cde2c2-dac7-4cdb-8329-c2f88ebd4f984
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN548d0e95-6116-47bc-ab35-2eda2a1638752
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN439bb230-94d8-4522-ad79-5cce5fad965b2
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD548d0e95-6116-47bc-ab35-2eda2a1638752
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD439bb230-94d8-4522-ad79-5cce5fad965b2
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY548d0e95-6116-47bc-ab35-2eda2a1638752
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY439bb230-94d8-4522-ad79-5cce5fad965b2
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNb8d22cd5-11b0-48d8-afbe-69d831295b771
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNc7a29365-76f1-42dc-9891-e13e54295d521
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDb8d22cd5-11b0-48d8-afbe-69d831295b771
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDc7a29365-76f1-42dc-9891-e13e54295d521
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYb8d22cd5-11b0-48d8-afbe-69d831295b771
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYc7a29365-76f1-42dc-9891-e13e54295d521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62756-142-0162756014201100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62756-142-01) 2006-02-090000-00-00NoNoCurrent
62756-142-0262756014202500 TABLET, EXTENDED RELEASE in 1 BOTTLE (62756-142-02) 2006-02-090000-00-00NoNoCurrent