FDA.reportPublic FDA data

SEGLUROMET

Product NDC
0006-5374
11-digit product format
000065374
Labeler code
0006
Product ID
0006-5374_1981063d-b592-4847-ac6d-ba85722bd1d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ertugliflozin and metformin hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Merck Sharp & Dohme LLC
Application
NDA209806
Marketing category
NDA
Marketing start
2017-12-19
Substance
ERTUGLIFLOZIN PIDOLATE; METFORMIN HYDROCHLORIDE
Active strength
7.5; 1000 mg/1; 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
SEGLUROMET
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERTUGLIFLOZIN PIDOLATE7.5 mg/1
METFORMIN HYDROCHLORIDE1000 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii786Z46389E, MLU731K321
Rxcui1992685, 1992691, 1992693, 1992695, 1992698, 1992700, 1992701, 1992703

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
63c50ce2-9db8-486b-bf11-659e923f6f07Product name220250331
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
fd232072-39c4-4416-9b66-265d18a7bd93Product 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
0006-5374-032020-08-14C16284748780-1ab0e2407-2e2c-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use SEGLUROMET safely and effectively. See full prescribing information for SEGLUROMET. SEGLUROMET ® (ertugliflozin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 2017
0006-5374-062020-08-14C16284748780-1ab0e2407-2e2c-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use SEGLUROMET safely and effectively. See full prescribing information for SEGLUROMET. SEGLUROMET ® (ertugliflozin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 2017
0006-5374-072020-08-14C16284748780-1ab0e2407-2e2c-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use SEGLUROMET safely and effectively. See full prescribing information for SEGLUROMET. SEGLUROMET ® (ertugliflozin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 2017
0006-5374-092020-08-14C16284748780-1ab0e2407-2e2c-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use SEGLUROMET safely and effectively. See full prescribing information for SEGLUROMET. SEGLUROMET ® (ertugliflozin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 2017
0006-5374-032020-07-22C16284748780-1ab0e2407-2e2c-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use SEGLUROMET safely and effectively. See full prescribing information for SEGLUROMET. SEGLUROMET ® (ertugliflozin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 2017
0006-5374-062020-07-22C16284748780-1ab0e2407-2e2c-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use SEGLUROMET safely and effectively. See full prescribing information for SEGLUROMET. SEGLUROMET ® (ertugliflozin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 2017
0006-5374-072020-07-22C16284748780-1ab0e2407-2e2c-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use SEGLUROMET safely and effectively. See full prescribing information for SEGLUROMET. SEGLUROMET ® (ertugliflozin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 2017
0006-5374-092020-07-22C16284748780-1ab0e2407-2e2c-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use SEGLUROMET safely and effectively. See full prescribing information for SEGLUROMET. SEGLUROMET ® (ertugliflozin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 2017

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-5374-03SEGLUROMET60 in 1 BOTTLETABLET, FILM COATED6019
0006-5374-06SEGLUROMET180 in 1 BOTTLETABLET, FILM COATED18019
0006-5374-07SEGLUROMET500 in 1 BOTTLETABLET, FILM COATED50019
0006-5374-08SEGLUROMET14 in 1 BOTTLETABLET, FILM COATED1419
0006-5374-09SEGLUROMET2 in 1 CARTONTABLET, FILM COATED219

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-5374-03EA - Each0006-5374db10afd7-6958-48e4-ac86-1d10d21fe27712018-03-08
0006-5374-06EA - Each0006-53741bea6e8f-dab7-49f0-a5e2-78c0bff7641a12018-03-08
0006-5374-07EA - Each0006-5374355ac7f3-3c82-4759-9e12-e879d601854612019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-5374SEGLUROMET (ERTUGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME LLC]19Current NDC, Legacy NDC, 5 package rows20250112_a6aeb99a-ce49-4125-90ce-642df3f1ebad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1992685ertugliflozin 2.5 MG / metFORMIN hydrochloride 1000 MG Oral TabletPSNa6aeb99a-ce49-4125-90ce-642df3f1ebad19
1992693ertugliflozin 2.5 MG / metFORMIN hydrochloride 500 MG Oral TabletPSNa6aeb99a-ce49-4125-90ce-642df3f1ebad19
1992698ertugliflozin 7.5 MG / metFORMIN hydrochloride 1000 MG Oral TabletPSNa6aeb99a-ce49-4125-90ce-642df3f1ebad19
1992701ertugliflozin 7.5 MG / metFORMIN hydrochloride 500 MG Oral TabletPSNa6aeb99a-ce49-4125-90ce-642df3f1ebad19
1992691Segluromet 2.5 MG / 1000 MG Oral TabletPSNa6aeb99a-ce49-4125-90ce-642df3f1ebad19
1992695Segluromet 2.5 MG / 500 MG Oral TabletPSNa6aeb99a-ce49-4125-90ce-642df3f1ebad19
1992700Segluromet 7.5 MG / 1000 MG Oral TabletPSNa6aeb99a-ce49-4125-90ce-642df3f1ebad19
1992703Segluromet 7.5 MG / 500 MG Oral TabletPSNa6aeb99a-ce49-4125-90ce-642df3f1ebad19
1992691ertugliflozin 2.5 MG / metformin hydrochloride 1000 MG Oral Tablet [Segluromet]SBDa6aeb99a-ce49-4125-90ce-642df3f1ebad19
1992695ertugliflozin 2.5 MG / metformin hydrochloride 500 MG Oral Tablet [Segluromet]SBDa6aeb99a-ce49-4125-90ce-642df3f1ebad19
1992700ertugliflozin 7.5 MG / metformin hydrochloride 1000 MG Oral Tablet [Segluromet]SBDa6aeb99a-ce49-4125-90ce-642df3f1ebad19
1992703ertugliflozin 7.5 MG / metformin hydrochloride 500 MG Oral Tablet [Segluromet]SBDa6aeb99a-ce49-4125-90ce-642df3f1ebad19
1992685ertugliflozin 2.5 MG / metformin hydrochloride 1000 MG Oral TabletSCDa6aeb99a-ce49-4125-90ce-642df3f1ebad19
1992693ertugliflozin 2.5 MG / metformin hydrochloride 500 MG Oral TabletSCDa6aeb99a-ce49-4125-90ce-642df3f1ebad19
1992698ertugliflozin 7.5 MG / metformin hydrochloride 1000 MG Oral TabletSCDa6aeb99a-ce49-4125-90ce-642df3f1ebad19
1992701ertugliflozin 7.5 MG / metformin hydrochloride 500 MG Oral TabletSCDa6aeb99a-ce49-4125-90ce-642df3f1ebad19
1992691Segluromet 2.5/1000 (ertugliflozin 2.5 MG / metformin hydrochloride 1000 MG) MG Oral TabletSYa6aeb99a-ce49-4125-90ce-642df3f1ebad19
1992691Segluromet 2.5/1000 Oral TabletSYa6aeb99a-ce49-4125-90ce-642df3f1ebad19
1992695Segluromet 2.5/500 (ertugliflozin 2.5 MG / metformin hydrochloride 500 MG) MG Oral TabletSYa6aeb99a-ce49-4125-90ce-642df3f1ebad19
1992695Segluromet 2.5/500 Oral TabletSYa6aeb99a-ce49-4125-90ce-642df3f1ebad19
1992700Segluromet 7.5/1000 (ertugliflozin 7.5 MG / metformin hydrochloride 1000 MG) MG Oral TabletSYa6aeb99a-ce49-4125-90ce-642df3f1ebad19
1992700Segluromet 7.5/1000 Oral TabletSYa6aeb99a-ce49-4125-90ce-642df3f1ebad19
1992703Segluromet 7.5/500 (ertugliflozin 7.5 MG / metformin hydrochloride 500 MG) MG Oral TabletSYa6aeb99a-ce49-4125-90ce-642df3f1ebad19
1992703Segluromet 7.5/500 Oral TabletSYa6aeb99a-ce49-4125-90ce-642df3f1ebad19
1992698ertugliflozin 7.5 MG / metFORMIN hydrochloride 1000 MG Oral TabletPSN8efac46d-d6bb-483a-825d-60bba09d3c173
1992700Segluromet 7.5 MG / 1000 MG Oral TabletPSN8efac46d-d6bb-483a-825d-60bba09d3c173
1992700ertugliflozin 7.5 MG / metformin hydrochloride 1000 MG Oral Tablet [Segluromet]SBD8efac46d-d6bb-483a-825d-60bba09d3c173
1992698ertugliflozin 7.5 MG / metformin hydrochloride 1000 MG Oral TabletSCD8efac46d-d6bb-483a-825d-60bba09d3c173
1992700Segluromet 7.5/1000 (ertugliflozin 7.5 MG / metformin hydrochloride 1000 MG) MG Oral TabletSY8efac46d-d6bb-483a-825d-60bba09d3c173
1992700Segluromet 7.5/1000 Oral TabletSY8efac46d-d6bb-483a-825d-60bba09d3c173

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0006-5374-030000653740360 TABLET, FILM COATED in 1 BOTTLE (0006-5374-03) 2017-12-190000-00-00NoNoCurrent
0006-5374-0600006537406180 TABLET, FILM COATED in 1 BOTTLE (0006-5374-06) 2017-12-190000-00-00NoNoCurrent
0006-5374-0700006537407500 TABLET, FILM COATED in 1 BOTTLE (0006-5374-07) 2017-12-190000-00-00NoNoCurrent
0006-5374-080000653740814 in 1 BOTTLEHistorical
0006-5374-09000065374092 BOTTLE in 1 CARTON (0006-5374-09) / 14 TABLET, FILM COATED in 1 BOTTLE (0006-5374-08) 2 bottle2017-12-190000-00-00YesNoCurrent