FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
65862-008
11-digit product format
658620008
Labeler code
65862
Product ID
65862-008_1c59d7bc-6118-4707-80c0-886ac00bab09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA077095
Marketing category
ANDA
Marketing start
2005-01-14
Substance
METFORMIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metformin Hydrochloride
Listing expiration
2027-12-31

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
65862-008-01Metformin Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10016
65862-008-05Metformin Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50016
65862-008-33Metformin Hydrochloride300 in 1 BOTTLETABLET, FILM COATED30016
65862-008-45Metformin Hydrochloride4500 in 1 BOTTLETABLET, FILM COATED450016
65862-008-50Metformin Hydrochloride50 in 1 BOTTLETABLET, FILM COATED5016
65862-008-60Metformin Hydrochloride60 in 1 BOTTLETABLET, FILM COATED6016
65862-008-90Metformin Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9016
65862-008-99Metformin Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-008-01EA - Each65862-00849e7fa08-e030-4c01-b32d-46fe0ee1a34c12012-07-24
65862-008-05EA - Each65862-0082e301e1a-6076-4be6-a9c7-655948c3e10d12012-07-24
65862-008-90EA - Each65862-0085dfe1855-7a7e-43dc-bc0b-779231596e1f12012-07-24
65862-008-99EA - Each65862-00830a94890-de62-4295-aec3-55158c780e2612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-008METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15Current NDC, Legacy NDC, 8 package rows20240104_4ac6d01a-af26-44e7-ae2e-3618de0080aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861004metFORMIN HCl 1000 MG Oral TabletPSN23aa50c5-28fe-4322-b5c6-1f1c48409b1638
861007metFORMIN HCl 500 MG Oral TabletPSN23aa50c5-28fe-4322-b5c6-1f1c48409b1638
861010metFORMIN HCl 850 MG Oral TabletPSN23aa50c5-28fe-4322-b5c6-1f1c48409b1638
861004metformin hydrochloride 1000 MG Oral TabletSCD23aa50c5-28fe-4322-b5c6-1f1c48409b1638
861007metformin hydrochloride 500 MG Oral TabletSCD23aa50c5-28fe-4322-b5c6-1f1c48409b1638
861010metformin hydrochloride 850 MG Oral TabletSCD23aa50c5-28fe-4322-b5c6-1f1c48409b1638
861004metformin HCl 1 GM Oral TabletSY23aa50c5-28fe-4322-b5c6-1f1c48409b1638
861004metFORMIN HCl 1000 MG Oral TabletPSN4ac6d01a-af26-44e7-ae2e-3618de0080aa16
861007metFORMIN HCl 500 MG Oral TabletPSN4ac6d01a-af26-44e7-ae2e-3618de0080aa16
861010metFORMIN HCl 850 MG Oral TabletPSN4ac6d01a-af26-44e7-ae2e-3618de0080aa16
861004metformin hydrochloride 1000 MG Oral TabletSCD4ac6d01a-af26-44e7-ae2e-3618de0080aa16
861007metformin hydrochloride 500 MG Oral TabletSCD4ac6d01a-af26-44e7-ae2e-3618de0080aa16
861010metformin hydrochloride 850 MG Oral TabletSCD4ac6d01a-af26-44e7-ae2e-3618de0080aa16
861004metformin HCl 1 GM Oral TabletSY4ac6d01a-af26-44e7-ae2e-3618de0080aa16
861004metFORMIN HCl 1000 MG Oral TabletPSN23aa0072-365c-4d13-9aa7-ae23f7e00ee415
861007metFORMIN HCl 500 MG Oral TabletPSN23aa0072-365c-4d13-9aa7-ae23f7e00ee415
861010metFORMIN HCl 850 MG Oral TabletPSN23aa0072-365c-4d13-9aa7-ae23f7e00ee415
861004metformin hydrochloride 1000 MG Oral TabletSCD23aa0072-365c-4d13-9aa7-ae23f7e00ee415
861007metformin hydrochloride 500 MG Oral TabletSCD23aa0072-365c-4d13-9aa7-ae23f7e00ee415
861010metformin hydrochloride 850 MG Oral TabletSCD23aa0072-365c-4d13-9aa7-ae23f7e00ee415
861004metformin HCl 1 GM Oral TabletSY23aa0072-365c-4d13-9aa7-ae23f7e00ee415
861007metFORMIN HCl 500 MG Oral TabletPSN073cf6d9-7142-4d8b-898e-174c62a1f76f14
861007metformin hydrochloride 500 MG Oral TabletSCD073cf6d9-7142-4d8b-898e-174c62a1f76f14
861007metFORMIN HCl 500 MG Oral TabletPSN1a7f7ef3-a94b-4ff6-a9f2-f5de4a99c7f65
861007metformin hydrochloride 500 MG Oral TabletSCD1a7f7ef3-a94b-4ff6-a9f2-f5de4a99c7f65
861004metFORMIN HCl 1000 MG Oral TabletPSN1b9b6db9-1bac-4252-a03c-18dc0271f05f4
861007metFORMIN HCl 500 MG Oral TabletPSN1b9b6db9-1bac-4252-a03c-18dc0271f05f4
861004metformin hydrochloride 1000 MG Oral TabletSCD1b9b6db9-1bac-4252-a03c-18dc0271f05f4
861007metformin hydrochloride 500 MG Oral TabletSCD1b9b6db9-1bac-4252-a03c-18dc0271f05f4
861004metformin HCl 1 GM Oral TabletSY1b9b6db9-1bac-4252-a03c-18dc0271f05f4
861007metFORMIN HCl 500 MG Oral TabletPSN6440960f-9b8d-021c-e053-2a91aa0a3eed3
861007metformin hydrochloride 500 MG Oral TabletSCD6440960f-9b8d-021c-e053-2a91aa0a3eed3
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNa7999fa7-886f-33c7-e053-2995a90aa3f51
861007metFORMIN HCl 500 MG Oral TabletPSN390c3bdf-bfaf-203e-e063-6394a90a7d201
861007metFORMIN HCl 500 MG Oral TabletPSN40e35fa9-9cfe-04f1-e054-00144ff8d46c1
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDa7999fa7-886f-33c7-e053-2995a90aa3f51
861007metformin hydrochloride 500 MG Oral TabletSCD390c3bdf-bfaf-203e-e063-6394a90a7d201
861007metformin hydrochloride 500 MG Oral TabletSCD40e35fa9-9cfe-04f1-e054-00144ff8d46c1
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYa7999fa7-886f-33c7-e053-2995a90aa3f51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-008-0165862000801100 TABLET, FILM COATED in 1 BOTTLE (65862-008-01) 2005-01-140000-00-00NoNoCurrent
65862-008-0565862000805500 TABLET, FILM COATED in 1 BOTTLE (65862-008-05) 2005-01-140000-00-00NoNoCurrent
65862-008-26658620008262500 TABLET, FILM COATED in 1 BAG (65862-008-26)14-JAN-05Current
65862-008-3365862000833300 TABLET, FILM COATED in 1 BOTTLE (65862-008-33) 2005-01-140000-00-00NoNoCurrent
65862-008-45658620008454500 TABLET, FILM COATED in 1 BOTTLE (65862-008-45) 2005-01-140000-00-00NoNoCurrent
65862-008-49658620008494000 TABLET, FILM COATED in 1 BAG (65862-008-49)14-JAN-05Current
65862-008-506586200085050 TABLET, FILM COATED in 1 BOTTLE (65862-008-50) 2005-01-140000-00-00NoNoCurrent
65862-008-566586200085656000 TABLET, FILM COATED in 1 BAG (65862-008-56)14-JAN-05Current
65862-008-606586200086060 TABLET, FILM COATED in 1 BOTTLE (65862-008-60) 2005-01-140000-00-00NoNoCurrent
65862-008-906586200089090 TABLET, FILM COATED in 1 BOTTLE (65862-008-90) 2005-01-140000-00-00NoNoCurrent
65862-008-99658620008991000 TABLET, FILM COATED in 1 BOTTLE (65862-008-99) 2005-01-140000-00-00NoNoCurrent