FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
70518-2833
11-digit product format
705182833
Labeler code
70518
Product ID
70518-2833_4e4322ac-9a90-2485-e063-6294a90a1d39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090564
Marketing category
ANDA
Marketing start
2020-08-14
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
Rxcui861007

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2833-02022-02-07C16284748780-1d6a99b39-93a5-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995
70518-2833-02022-02-07C16284748780-1d6a99b39-93a5-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995
70518-2833-02022-02-07C16284748780-1d6a99b39-93a5-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995
70518-2833-02022-02-07C16284748780-1d6a99b39-93a5-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995
70518-2833-02022-01-28C16284748780-1d6a99b39-93a5-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995
70518-2833-02022-01-28C16284748780-1d6a99b39-93a5-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995
70518-2833-02022-01-28C16284748780-1d6a99b39-93a5-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995
70518-2833-02022-01-28C16284748780-1d6a99b39-93a5-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2833-0Metformin Hydrochloride30 in 1 BLISTER PACKTABLET3020
70518-2833-1Metformin Hydrochloride90 in 1 BOTTLE, PLASTICTABLET9020
70518-2833-2Metformin Hydrochloride180 in 1 BOTTLE, PLASTICTABLET18020
70518-2833-3Metformin Hydrochloride120 in 1 BOTTLE, PLASTICTABLET12020
70518-2833-4Metformin Hydrochloride60 in 1 BLISTER PACKTABLET6020
70518-2833-5Metformin Hydrochloride30 in 1 BLISTER PACKTABLET3020
70518-2833-6Metformin Hydrochloride30 in 1 BOTTLE, PLASTICTABLET3020
70518-2833-7Metformin Hydrochloride100 in 1 BOTTLE, PLASTICTABLET10020
70518-2833-8Metformin Hydrochloride30 in 1 BOTTLE, PLASTICTABLET3020
70518-2833-9Metformin Hydrochloride30 in 1 BLISTER PACKTABLET3020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2833METFORMIN HYDROCHLORIDE TABLET [REMEDYREPACK INC.]15Current NDC, Legacy NDC, 10 package rows20250423_30658e19-8e6e-49aa-a007-e414224797c5.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2833-07051828330030 TABLET in 1 BLISTER PACK (70518-2833-0) 30 tablet2020-08-140000-00-00NoNoCurrent
70518-2833-17051828330190 TABLET in 1 BOTTLE, PLASTIC (70518-2833-1) 90 tablet2022-07-250000-00-00NoNoCurrent
70518-2833-270518283302180 TABLET in 1 BOTTLE, PLASTIC (70518-2833-2) 180 tablet2022-08-030000-00-00NoNoCurrent
70518-2833-370518283303120 TABLET in 1 BOTTLE, PLASTIC (70518-2833-3) 120 tablet2022-12-200000-00-00NoNoCurrent
70518-2833-47051828330460 TABLET in 1 BLISTER PACK (70518-2833-4) 60 tablet2023-09-25NoNoHistorical
70518-2833-57051828330530 TABLET in 1 BLISTER PACK (70518-2833-5) 30 tablet2023-12-09NoNoHistorical
70518-2833-67051828330630 in 1 BOTTLE, PLASTICHistorical
70518-2833-770518283307100 TABLET in 1 BOTTLE, PLASTIC (70518-2833-7) 100 tablet2025-03-20NoNoHistorical
70518-2833-87051828330830 in 1 BOTTLE, PLASTICHistorical
70518-2833-97051828330930 TABLET in 1 BLISTER PACK (70518-2833-9) 30 tablet2025-06-09NoNoHistorical