FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
57664-474
11-digit product format
576640474
Labeler code
57664
Product ID
57664-474_7274fdaf-11f8-2b2f-e053-2991aa0ad3f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA075967
Marketing category
ANDA
Marketing start
2002-01-29
Marketing end
0000-00-00
Substance
METFORMIN HYDROCHLORIDE
Active strength
1000 mg/1
Pharmacologic classes
Biguanide [EPC],Biguanides [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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
57664-474-51EA - Each57664-4742040b13c-24e2-43a0-8c8e-b1cfc9abaea412012-07-24
57664-474-53EA - Each57664-474726f6f8d-1829-4e4e-93a2-6f099a02503512012-07-24
57664-474-58EA - Each57664-474d7465e04-c295-4a71-bc25-d7fe02ca2b8d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]5
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMETFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]5
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]5
TRIACETININACTIVE INGREDIENTXHX3C3X673METFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE TABLET [MED-HEALTH PHARMA, LLC]5
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETFORMIN HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETFORMIN HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMETFORMIN HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETFORMIN HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETFORMIN HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
TRIACETININACTIVE INGREDIENTXHX3C3X673METFORMIN HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOMETFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMETFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AMETFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KMETFORMIN HYDROCHLORIDE TABLET METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETFORMIN HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETFORMIN HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AMETFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMETFORMIN HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EMETFORMIN HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETFORMIN HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
TRIACETININACTIVE INGREDIENTXHX3C3X673METFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673METFORMIN HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861004metFORMIN HCl 1000 MG Oral TabletPSN416a6446-81cc-43af-8d9c-788c91a2a1d35
861007metFORMIN HCl 500 MG Oral TabletPSN416a6446-81cc-43af-8d9c-788c91a2a1d35
861010metFORMIN HCl 850 MG Oral TabletPSN416a6446-81cc-43af-8d9c-788c91a2a1d35
861004metformin hydrochloride 1000 MG Oral TabletSCD416a6446-81cc-43af-8d9c-788c91a2a1d35
861007metformin hydrochloride 500 MG Oral TabletSCD416a6446-81cc-43af-8d9c-788c91a2a1d35
861010metformin hydrochloride 850 MG Oral TabletSCD416a6446-81cc-43af-8d9c-788c91a2a1d35
861004metformin HCl 1 GM Oral TabletSY416a6446-81cc-43af-8d9c-788c91a2a1d35
861004metFORMIN HCl 1000 MG Oral TabletPSNc80870d1-b42f-4478-9844-7eebf99d43a34
861007metFORMIN HCl 500 MG Oral TabletPSNc80870d1-b42f-4478-9844-7eebf99d43a34
861010metFORMIN HCl 850 MG Oral TabletPSNc80870d1-b42f-4478-9844-7eebf99d43a34
861004metformin hydrochloride 1000 MG Oral TabletSCDc80870d1-b42f-4478-9844-7eebf99d43a34
861007metformin hydrochloride 500 MG Oral TabletSCDc80870d1-b42f-4478-9844-7eebf99d43a34
861010metformin hydrochloride 850 MG Oral TabletSCDc80870d1-b42f-4478-9844-7eebf99d43a34
861004metformin HCl 1 GM Oral TabletSYc80870d1-b42f-4478-9844-7eebf99d43a34
861004metFORMIN HCl 1000 MG Oral TabletPSNf0a43cae-0f19-4a60-8a82-895cc4ea00012
861007metFORMIN HCl 500 MG Oral TabletPSNf0a43cae-0f19-4a60-8a82-895cc4ea00012
861010metFORMIN HCl 850 MG Oral TabletPSNf0a43cae-0f19-4a60-8a82-895cc4ea00012
861004metformin hydrochloride 1000 MG Oral TabletSCDf0a43cae-0f19-4a60-8a82-895cc4ea00012
861007metformin hydrochloride 500 MG Oral TabletSCDf0a43cae-0f19-4a60-8a82-895cc4ea00012
861010metformin hydrochloride 850 MG Oral TabletSCDf0a43cae-0f19-4a60-8a82-895cc4ea00012
861004metformin HCl 1 GM Oral TabletSYf0a43cae-0f19-4a60-8a82-895cc4ea00012
861004metFORMIN HCl 1000 MG Oral TabletPSN5056dc66-b0c1-47a1-acf6-5b0e1a7fb5561
861004metFORMIN HCl 1000 MG Oral TabletPSN495738b9-2511-446b-833c-164c0119035b1
861007metFORMIN HCl 500 MG Oral TabletPSN495738b9-2511-446b-833c-164c0119035b1
861010metFORMIN HCl 850 MG Oral TabletPSN495738b9-2511-446b-833c-164c0119035b1
861004metformin hydrochloride 1000 MG Oral TabletSCD5056dc66-b0c1-47a1-acf6-5b0e1a7fb5561
861004metformin hydrochloride 1000 MG Oral TabletSCD495738b9-2511-446b-833c-164c0119035b1
861007metformin hydrochloride 500 MG Oral TabletSCD495738b9-2511-446b-833c-164c0119035b1
861010metformin hydrochloride 850 MG Oral TabletSCD495738b9-2511-446b-833c-164c0119035b1
861004metformin HCl 1 GM Oral TabletSY5056dc66-b0c1-47a1-acf6-5b0e1a7fb5561
861004metformin HCl 1 GM Oral TabletSY495738b9-2511-446b-833c-164c0119035b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57664-474-5157664047451100 TABLET in 1 BOTTLE (57664-474-51) 100 tablet2002-01-290000-00-00NoNoCurrent
57664-474-5357664047453500 TABLET in 1 BOTTLE (57664-474-53) 500 tablet2002-01-290000-00-00NoNoCurrent
57664-474-58576640474581000 TABLET in 1 BOTTLE (57664-474-58) 1000 tablet2002-01-290000-00-00NoNoCurrent
57664-474-595766404745990 TABLET in 1 BOTTLE (57664-474-59) 90 tablet2002-01-290000-00-00NoNoCurrent