FDA.reportPublic FDA data

Metformin HCl

Product NDC
67877-561
11-digit product format
678770561
Labeler code
67877
Product ID
67877-561_2d98aea3-35ba-447a-b88f-a5a20b612b2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin HCl
Dosage form
TABLET
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA090564
Marketing category
ANDA
Marketing start
2017-02-06
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 HCl
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
67877-561-01Metformin HCl100 in 1 BOTTLETABLET1001
67877-561-05Metformin HCl500 in 1 BOTTLETABLET5001
67877-561-10Metformin HCl1000 in 1 BOTTLETABLET10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-561-01EA - Each67877-56116ee8633-4ff0-4d03-b5ff-dd87e634442612017-07-07
67877-561-05EA - Each67877-561a124ef96-9dc9-4d66-a6cb-7793750e7e1512017-06-15
67877-561-10EA - Each67877-561673e398c-b56b-42ec-8791-6738644d7ccf12017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-561METFORMIN HCL TABLET [ASCEND LABORATORIES, LLC]1Current NDC, Legacy NDC, 3 package rows20170208_2d98aea3-35ba-447a-b88f-a5a20b612b2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861007metFORMIN HCl 500 MG Oral TabletPSNfb890205-5d43-41eb-97b2-fb0dcdd3a95013
861007metFORMIN HCl 500 MG Oral TabletPSN4e345b8c-57ab-4f09-9cbe-1d255e9354ba13
861007metformin hydrochloride 500 MG Oral TabletSCDfb890205-5d43-41eb-97b2-fb0dcdd3a95013
861007metformin hydrochloride 500 MG Oral TabletSCD4e345b8c-57ab-4f09-9cbe-1d255e9354ba13
861004metFORMIN HCl 1000 MG Oral TabletPSN06ade2e1-5981-4e3d-b7e9-7ff083eb45517
861007metFORMIN HCl 500 MG Oral TabletPSN06ade2e1-5981-4e3d-b7e9-7ff083eb45517
861004metformin hydrochloride 1000 MG Oral TabletSCD06ade2e1-5981-4e3d-b7e9-7ff083eb45517
861007metformin hydrochloride 500 MG Oral TabletSCD06ade2e1-5981-4e3d-b7e9-7ff083eb45517
861004metformin HCl 1 GM Oral TabletSY06ade2e1-5981-4e3d-b7e9-7ff083eb45517
861007metFORMIN HCl 500 MG Oral TabletPSN6a9db5bf-5315-3418-e053-2a91aa0ad15f6
861007metformin hydrochloride 500 MG Oral TabletSCD6a9db5bf-5315-3418-e053-2a91aa0ad15f6
861007metFORMIN HCl 500 MG Oral TabletPSN74f18a3e-0f5c-4172-b499-14f229b431c45
861007metformin hydrochloride 500 MG Oral TabletSCD74f18a3e-0f5c-4172-b499-14f229b431c45
861007metFORMIN HCl 500 MG Oral TabletPSN0b3d7c79-9a5a-a82e-e063-6394a90a3caa4
861007metformin hydrochloride 500 MG Oral TabletSCD0b3d7c79-9a5a-a82e-e063-6394a90a3caa4
861007metFORMIN HCl 500 MG Oral TabletPSNd2c927eb-12bf-4c7d-9ef5-0036b2dd8c293
861010metFORMIN HCl 850 MG Oral TabletPSNd2c927eb-12bf-4c7d-9ef5-0036b2dd8c293
861007metformin hydrochloride 500 MG Oral TabletSCDd2c927eb-12bf-4c7d-9ef5-0036b2dd8c293
861010metformin hydrochloride 850 MG Oral TabletSCDd2c927eb-12bf-4c7d-9ef5-0036b2dd8c293
861007metFORMIN HCl 500 MG Oral TabletPSN4bdd2faa-2125-4139-b958-196393e31b7e2
861007metFORMIN HCl 500 MG Oral TabletPSN13b1e35f-d047-8ddc-e063-6394a90a24dd2
861007metFORMIN HCl 500 MG Oral TabletPSNc8e50300-1838-4c51-8d9d-ebbaaf0f39912
861007metformin hydrochloride 500 MG Oral TabletSCD4bdd2faa-2125-4139-b958-196393e31b7e2
861007metformin hydrochloride 500 MG Oral TabletSCD13b1e35f-d047-8ddc-e063-6394a90a24dd2
861007metformin hydrochloride 500 MG Oral TabletSCDc8e50300-1838-4c51-8d9d-ebbaaf0f39912
861004metFORMIN HCl 1000 MG Oral TabletPSN2d98aea3-35ba-447a-b88f-a5a20b612b2f1
861007metFORMIN HCl 500 MG Oral TabletPSN2d98aea3-35ba-447a-b88f-a5a20b612b2f1
861007metFORMIN HCl 500 MG Oral TabletPSNaffda99e-5aa7-4d78-971f-41d9a151b5c51
861007metFORMIN HCl 500 MG Oral TabletPSN408b6026-a94a-4723-b5e4-4a309e3f735f1
861010metFORMIN HCl 850 MG Oral TabletPSN2d98aea3-35ba-447a-b88f-a5a20b612b2f1
861004metformin hydrochloride 1000 MG Oral TabletSCD2d98aea3-35ba-447a-b88f-a5a20b612b2f1
861007metformin hydrochloride 500 MG Oral TabletSCDaffda99e-5aa7-4d78-971f-41d9a151b5c51
861007metformin hydrochloride 500 MG Oral TabletSCD408b6026-a94a-4723-b5e4-4a309e3f735f1
861007metformin hydrochloride 500 MG Oral TabletSCD2d98aea3-35ba-447a-b88f-a5a20b612b2f1
861010metformin hydrochloride 850 MG Oral TabletSCD2d98aea3-35ba-447a-b88f-a5a20b612b2f1
861004metformin HCl 1 GM Oral TabletSY2d98aea3-35ba-447a-b88f-a5a20b612b2f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-561-0167877056101100 TABLET in 1 BOTTLE (67877-561-01) 100 tablet2017-02-060000-00-00NoNoCurrent
67877-561-0567877056105500 TABLET in 1 BOTTLE (67877-561-05) 500 tablet2017-02-060000-00-00NoNoCurrent
67877-561-10678770561101000 TABLET in 1 BOTTLE (67877-561-10) 1000 tablet2017-02-060000-00-00NoNoCurrent