FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
70010-065
11-digit product format
700100065
Labeler code
70010
Product ID
70010-065_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
1000 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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METFORMIN HYDROCHLORIDE1000 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
70010-065-01Metformin Hydrochloride100 in 1 BOTTLETABLET1006
70010-065-05Metformin Hydrochloride500 in 1 BOTTLETABLET5006
70010-065-06Metformin Hydrochloride60 in 1 BOTTLETABLET606
70010-065-09Metformin Hydrochloride90 in 1 BOTTLETABLET906
70010-065-10Metformin Hydrochloride1000 in 1 BOTTLETABLET10006
70010-065-99Metformin Hydrochloride1000 in 1 BOTTLETABLET10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-065-01EA - Each70010-065f7a485d2-9944-4858-a846-d3814bd9d7c012020-05-08
70010-065-05EA - Each70010-06549c99d4f-cd4c-4603-8e38-faa53035fc6512020-05-08
70010-065-09EA - Each70010-06591136504-88b5-4bb6-aa25-9a85251525c812021-04-08
70010-065-10EA - Each70010-06592dfbca6-c6a2-466d-bedc-c4472c33a20012020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-065METFORMIN HYDROCHLORIDE TABLET [GRANULES PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 6 package rows20230810_2387a618-24d8-4813-aa83-9114edb35374.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 TabletPSN59a4ccda-5487-4ac4-9373-0c0fc8b7c88b13
861004metformin hydrochloride 1000 MG Oral TabletSCD59a4ccda-5487-4ac4-9373-0c0fc8b7c88b13
861004metformin HCl 1 GM Oral TabletSY59a4ccda-5487-4ac4-9373-0c0fc8b7c88b13
861004metFORMIN HCl 1000 MG Oral TabletPSN2387a618-24d8-4813-aa83-9114edb353746
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 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 TabletPSN1ef6c527-89f5-4830-8900-7532b0a7ef265
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
861004metformin hydrochloride 1000 MG Oral TabletSCD1ef6c527-89f5-4830-8900-7532b0a7ef265
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
861004metformin HCl 1 GM Oral TabletSY1ef6c527-89f5-4830-8900-7532b0a7ef265
861004metFORMIN HCl 1000 MG Oral TabletPSN5f243894-bda3-4fa9-97e4-209dcb389dee4
861004metformin hydrochloride 1000 MG Oral TabletSCD5f243894-bda3-4fa9-97e4-209dcb389dee4
861004metformin HCl 1 GM Oral TabletSY5f243894-bda3-4fa9-97e4-209dcb389dee4
861004metFORMIN HCl 1000 MG Oral TabletPSN62ca8af4-ff91-4bf6-b7c6-895b3b5ce8c33
861004metFORMIN HCl 1000 MG Oral TabletPSNdae7b1c1-7ff1-883c-e053-2a95a90a1a2b3
861004metFORMIN HCl 1000 MG Oral TabletPSN1c046303-993c-4111-ac9a-40a0d97ca6a23
861004metformin hydrochloride 1000 MG Oral TabletSCD1c046303-993c-4111-ac9a-40a0d97ca6a23
861004metformin hydrochloride 1000 MG Oral TabletSCDdae7b1c1-7ff1-883c-e053-2a95a90a1a2b3
861004metformin hydrochloride 1000 MG Oral TabletSCD62ca8af4-ff91-4bf6-b7c6-895b3b5ce8c33
861004metformin HCl 1 GM Oral TabletSY62ca8af4-ff91-4bf6-b7c6-895b3b5ce8c33
861004metformin HCl 1 GM Oral TabletSY1c046303-993c-4111-ac9a-40a0d97ca6a23
861004metformin HCl 1 GM Oral TabletSYdae7b1c1-7ff1-883c-e053-2a95a90a1a2b3
861004metFORMIN HCl 1000 MG Oral TabletPSN34aa1761-d16f-4bfc-b7fa-bf1b0387e8a32
861004metformin hydrochloride 1000 MG Oral TabletSCD34aa1761-d16f-4bfc-b7fa-bf1b0387e8a32
861004metformin HCl 1 GM Oral TabletSY34aa1761-d16f-4bfc-b7fa-bf1b0387e8a32
861004metFORMIN HCl 1000 MG Oral TabletPSNbc3e7bea-68c3-d132-e053-2a95a90af7a01
861004metformin hydrochloride 1000 MG Oral TabletSCDbc3e7bea-68c3-d132-e053-2a95a90af7a01
861004metformin HCl 1 GM Oral TabletSYbc3e7bea-68c3-d132-e053-2a95a90af7a01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70010-065-0170010006501100 TABLET in 1 BOTTLE (70010-065-01) 100 tablet2019-06-260000-00-00NoNoCurrent
70010-065-0570010006505500 TABLET in 1 BOTTLE (70010-065-05) 500 tablet2019-06-260000-00-00NoNoCurrent
70010-065-067001000650660 TABLET in 1 BOTTLE (70010-065-06) 60 tablet2019-06-260000-00-00NoNoCurrent
70010-065-097001000650990 TABLET in 1 BOTTLE (70010-065-09) 90 tablet2019-06-260000-00-00NoNoCurrent
70010-065-10700100065101000 TABLET in 1 BOTTLE (70010-065-10) 1000 tablet2019-06-260000-00-00NoNoCurrent
70010-065-177001000651727916 TABLET in 1 DRUM (70010-065-17)27916 tablet07-JUN-19Current
70010-065-99700100065991000 TABLET in 1 BOTTLE (70010-065-99) 1000 tablet2023-08-09NoNoCurrent