FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
70518-3084
11-digit product format
705183084
Labeler code
70518
Product ID
70518-3084_4e914721-fd0f-dda0-e063-6394a90aabfd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090564
Marketing category
ANDA
Marketing start
2021-05-04
Substance
METFORMIN HYDROCHLORIDE
Active strength
850 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 HYDROCHLORIDE850 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii786Z46389E
Rxcui861010

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
70518-3084-0Metformin Hydrochloride30 in 1 BLISTER PACKTABLET3016
70518-3084-1Metformin Hydrochloride180 in 1 BOTTLE, PLASTICTABLET18016
70518-3084-2Metformin Hydrochloride90 in 1 BOTTLE, PLASTICTABLET9016
70518-3084-3Metformin Hydrochloride30 in 1 BLISTER PACKTABLET3016
70518-3084-4Metformin Hydrochloride90 in 1 BOTTLE, PLASTICTABLET9016
70518-3084-5Metformin Hydrochloride30 in 1 BLISTER PACKTABLET3016
70518-3084-6Metformin Hydrochloride180 in 1 BOTTLE, PLASTICTABLET18016
70518-3084-7Metformin Hydrochloride100 in 1 BOTTLE, PLASTICTABLET10016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3084METFORMIN HYDROCHLORIDE TABLET [REMEDYREPACK INC.]12Current NDC, Legacy NDC, 8 package rows20250503_1e8136e0-cc98-41e4-ad4b-a8fc27fb4daa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861010metFORMIN HCl 850 MG Oral TabletPSN1e8136e0-cc98-41e4-ad4b-a8fc27fb4daa16
861010metformin hydrochloride 850 MG Oral TabletSCD1e8136e0-cc98-41e4-ad4b-a8fc27fb4daa16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3084-07051830840030 TABLET in 1 BLISTER PACK (70518-3084-0) 30 tablet2021-05-040000-00-00NoNoCurrent
70518-3084-170518308401180 TABLET in 1 BOTTLE, PLASTIC (70518-3084-1) 180 tablet2022-07-260000-00-00NoNoCurrent
70518-3084-27051830840290 TABLET in 1 BOTTLE, PLASTIC (70518-3084-2) 90 tablet2022-09-070000-00-00NoNoCurrent
70518-3084-37051830840330 TABLET in 1 BLISTER PACK (70518-3084-3) 30 tablet2024-04-16NoNoCurrent
70518-3084-47051830840490 TABLET in 1 BOTTLE, PLASTIC (70518-3084-4) 90 tablet2024-05-09NoNoCurrent
70518-3084-57051830840530 in 1 BLISTER PACKHistorical
70518-3084-670518308406180 TABLET in 1 BOTTLE, PLASTIC (70518-3084-6) 180 tablet2024-07-16NoNoCurrent
70518-3084-770518308407100 TABLET in 1 BOTTLE, PLASTIC (70518-3084-7) 100 tablet2025-03-19NoNoCurrent