FDA.reportPublic FDA data

METFORMIN HYDROCHLORIDE

Product NDC
42385-977
11-digit product format
423850977
Labeler code
42385
Product ID
42385-977_0e7b02cc-2ddc-4394-a80c-128e6452d697
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METFORMIN HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Laurus Labs Limited
Application
ANDA217631
Marketing category
ANDA
Marketing start
2023-10-06
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 HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METFORMIN HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii786Z46389E
Rxcui860975, 860981

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
42385-977-01METFORMIN HYDROCHLORIDE100 in 1 BOTTLETABLET, EXTENDED RELEASE1002
42385-977-05METFORMIN HYDROCHLORIDE500 in 1 BOTTLETABLET, EXTENDED RELEASE5002
42385-977-11METFORMIN HYDROCHLORIDE1000 in 1 BOTTLETABLET, EXTENDED RELEASE10002
42385-977-18METFORMIN HYDROCHLORIDE180 in 1 BOTTLETABLET, EXTENDED RELEASE1802
42385-977-30METFORMIN HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE302
42385-977-72METFORMIN HYDROCHLORIDE10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE102
42385-977-72METFORMIN HYDROCHLORIDE15 in 1 CARTONTABLET, EXTENDED RELEASE152
42385-977-90METFORMIN HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42385-977-01EA - Each42385-97786a472fd-6154-4bd7-b2ee-caa5264054be12024-07-12
42385-977-05EA - Each42385-9777ce8fd8f-8e5f-4059-b3d3-547dd1acfd7b12024-07-12
42385-977-11EA - Each42385-977ca6d3d7c-dbdf-4fda-a240-df3f6433e1fd12024-07-12
42385-977-90EA - Each42385-9777cb39cd6-1817-4b86-a470-d4191e18f7d612024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42385-977METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [LAURUS LABS LIMITED]1Current NDC, 8 package rows20231017_0e7b02cc-2ddc-4394-a80c-128e6452d697.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN0e7b02cc-2ddc-4394-a80c-128e6452d6972
860981metFORMIN HCl 750 MG 24HR Extended Release Oral TabletPSN0e7b02cc-2ddc-4394-a80c-128e6452d6972
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD0e7b02cc-2ddc-4394-a80c-128e6452d6972
86098124 HR metformin hydrochloride 750 MG Extended Release Oral TabletSCD0e7b02cc-2ddc-4394-a80c-128e6452d6972
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY0e7b02cc-2ddc-4394-a80c-128e6452d6972
860981metformin HCl 750 MG 24 HR Extended Release Oral TabletSY0e7b02cc-2ddc-4394-a80c-128e6452d6972
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN2d68fd88-c591-4577-a7c3-901338bdaf901
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN9fed67ea-7a15-4634-80cf-c975b8812ebe1
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN75b25738-31e6-4b58-9d2b-f4a1ab4ab0901
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN4db5551b-04f6-4921-9dee-68acb41f7f711
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN103080cb-6381-44f6-8a31-1fc81e7c890f1
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD2d68fd88-c591-4577-a7c3-901338bdaf901
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD4db5551b-04f6-4921-9dee-68acb41f7f711
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD75b25738-31e6-4b58-9d2b-f4a1ab4ab0901
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD103080cb-6381-44f6-8a31-1fc81e7c890f1
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD9fed67ea-7a15-4634-80cf-c975b8812ebe1
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY2d68fd88-c591-4577-a7c3-901338bdaf901
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY4db5551b-04f6-4921-9dee-68acb41f7f711
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY75b25738-31e6-4b58-9d2b-f4a1ab4ab0901
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY103080cb-6381-44f6-8a31-1fc81e7c890f1
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY9fed67ea-7a15-4634-80cf-c975b8812ebe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42385-977-0142385097701100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-977-01) 2023-10-06NoNoCurrent
42385-977-0542385097705500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-977-05) 2023-10-06NoNoCurrent
42385-977-11423850977111000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-977-11) 2023-10-06NoNoCurrent
42385-977-1842385097718180 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-977-18) 2023-10-06NoNoCurrent
42385-977-304238509773030 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-977-30) 2023-10-06NoNoCurrent
42385-977-724238509777215 BLISTER PACK in 1 CARTON (42385-977-72) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK15 blister pack2023-10-06NoNoCurrent
42385-977-904238509779090 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-977-90) 2023-10-06NoNoCurrent