FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
70010-063
11-digit product format
700100063
Labeler code
70010
Product ID
70010-063_0266503f-0f1a-38e0-e063-6294a90a606f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA090564
Marketing category
ANDA
Marketing start
2019-06-26
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
70010-063-01Metformin Hydrochloride100 in 1 BOTTLETABLET1006
70010-063-05Metformin Hydrochloride500 in 1 BOTTLETABLET5006
70010-063-06Metformin Hydrochloride60 in 1 BOTTLETABLET606
70010-063-09Metformin Hydrochloride90 in 1 BOTTLETABLET906
70010-063-10Metformin Hydrochloride1000 in 1 BOTTLETABLET10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-063-01EA - Each70010-063dd69ac30-ab57-471b-a990-fe8c539e204e12020-05-08
70010-063-05EA - Each70010-063be07ad10-0344-4c69-9e3f-f4136ad26c5912020-05-08
70010-063-09EA - Each70010-0637d9c517c-19dc-4a72-95cc-d7f4059f87c412021-04-08
70010-063-10EA - Each70010-063cf0824c7-284a-499a-8dd0-6edc240cbdee12020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-063METFORMIN HYDROCHLORIDE TABLET [GRANULES PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 5 package rows20230810_2387a618-24d8-4813-aa83-9114edb35374.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861007metFORMIN HCl 500 MG Oral TabletPSN30658e19-8e6e-49aa-a007-e414224797c520
861007metformin hydrochloride 500 MG Oral TabletSCD30658e19-8e6e-49aa-a007-e414224797c520
861004metFORMIN HCl 1000 MG Oral TabletPSNb51da8d7-ab4a-4c40-97c9-88bd379366d114
861007metFORMIN HCl 500 MG Oral TabletPSNb51da8d7-ab4a-4c40-97c9-88bd379366d114
861010metFORMIN HCl 850 MG Oral TabletPSNb51da8d7-ab4a-4c40-97c9-88bd379366d114
861004metformin hydrochloride 1000 MG Oral TabletSCDb51da8d7-ab4a-4c40-97c9-88bd379366d114
861007metformin hydrochloride 500 MG Oral TabletSCDb51da8d7-ab4a-4c40-97c9-88bd379366d114
861010metformin hydrochloride 850 MG Oral TabletSCDb51da8d7-ab4a-4c40-97c9-88bd379366d114
861004metformin HCl 1 GM Oral TabletSYb51da8d7-ab4a-4c40-97c9-88bd379366d114
861004metFORMIN HCl 1000 MG Oral TabletPSN2387a618-24d8-4813-aa83-9114edb353746
861007metFORMIN HCl 500 MG Oral TabletPSN011de1a5-1ac0-4831-9e8d-26ec79ba22056
861007metFORMIN HCl 500 MG Oral TabletPSN2387a618-24d8-4813-aa83-9114edb353746
861010metFORMIN HCl 850 MG Oral TabletPSN2387a618-24d8-4813-aa83-9114edb353746
861004metformin hydrochloride 1000 MG Oral TabletSCD2387a618-24d8-4813-aa83-9114edb353746
861007metformin hydrochloride 500 MG Oral TabletSCD011de1a5-1ac0-4831-9e8d-26ec79ba22056
861007metformin hydrochloride 500 MG Oral TabletSCD2387a618-24d8-4813-aa83-9114edb353746
861010metformin hydrochloride 850 MG Oral TabletSCD2387a618-24d8-4813-aa83-9114edb353746
861004metformin HCl 1 GM Oral TabletSY2387a618-24d8-4813-aa83-9114edb353746
861004metFORMIN HCl 1000 MG Oral TabletPSN5e783025-bf6d-465e-bf58-bcd253afad2c5
861007metFORMIN HCl 500 MG Oral TabletPSN5e783025-bf6d-465e-bf58-bcd253afad2c5
861010metFORMIN HCl 850 MG Oral TabletPSN5e783025-bf6d-465e-bf58-bcd253afad2c5
861004metformin hydrochloride 1000 MG Oral TabletSCD5e783025-bf6d-465e-bf58-bcd253afad2c5
861007metformin hydrochloride 500 MG Oral TabletSCD5e783025-bf6d-465e-bf58-bcd253afad2c5
861010metformin hydrochloride 850 MG Oral TabletSCD5e783025-bf6d-465e-bf58-bcd253afad2c5
861004metformin HCl 1 GM Oral TabletSY5e783025-bf6d-465e-bf58-bcd253afad2c5
861007metFORMIN HCl 500 MG Oral TabletPSNf31c08fc-cda1-349c-e053-2a95a90aba153
861007metformin hydrochloride 500 MG Oral TabletSCDf31c08fc-cda1-349c-e053-2a95a90aba153
861007metFORMIN HCl 500 MG Oral TabletPSNd51f3618-4166-4925-8994-968a653ebc462
861007metFORMIN HCl 500 MG Oral TabletPSN33550b88-d4bb-4ce6-a7db-07c966f6984f2
861007metformin hydrochloride 500 MG Oral TabletSCDd51f3618-4166-4925-8994-968a653ebc462
861007metformin hydrochloride 500 MG Oral TabletSCD33550b88-d4bb-4ce6-a7db-07c966f6984f2
861007metFORMIN HCl 500 MG Oral TabletPSN3c607f04-d36f-4cf8-9cc9-7f2af08b40981
861007metFORMIN HCl 500 MG Oral TabletPSNbb62088f-e9af-4644-9f57-cb90bab0f1991
861007metFORMIN HCl 500 MG Oral TabletPSN403349a1-ec19-8982-e063-6294a90aa0601
861007metFORMIN HCl 500 MG Oral TabletPSN7cc82387-8bb0-4bee-9967-cb13eab1d8011
861007metFORMIN HCl 500 MG Oral TabletPSN51285096-e2ce-0f3c-e063-6394a90a35d41
861007metFORMIN HCl 500 MG Oral TabletPSN59743092-bae1-4725-ac4b-c8a8b0a81c1e1
861007metformin hydrochloride 500 MG Oral TabletSCD403349a1-ec19-8982-e063-6294a90aa0601
861007metformin hydrochloride 500 MG Oral TabletSCD3c607f04-d36f-4cf8-9cc9-7f2af08b40981
861007metformin hydrochloride 500 MG Oral TabletSCD51285096-e2ce-0f3c-e063-6394a90a35d41
861007metformin hydrochloride 500 MG Oral TabletSCDbb62088f-e9af-4644-9f57-cb90bab0f1991
861007metformin hydrochloride 500 MG Oral TabletSCD7cc82387-8bb0-4bee-9967-cb13eab1d8011
861007metformin hydrochloride 500 MG Oral TabletSCD59743092-bae1-4725-ac4b-c8a8b0a81c1e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70010-063-0170010006301100 TABLET in 1 BOTTLE (70010-063-01) 100 tablet2019-06-260000-00-00NoNoCurrent
70010-063-0570010006305500 TABLET in 1 BOTTLE (70010-063-05) 500 tablet2019-06-260000-00-00NoNoCurrent
70010-063-067001000630660 TABLET in 1 BOTTLE (70010-063-06) 60 tablet2019-06-260000-00-00NoNoCurrent
70010-063-097001000630990 TABLET in 1 BOTTLE (70010-063-09) 90 tablet2019-06-260000-00-00NoNoCurrent
70010-063-10700100063101000 TABLET in 1 BOTTLE (70010-063-10) 1000 tablet2019-06-260000-00-00NoNoCurrent