Home NDC 0006-5369 SEGLUROMET
Product NDC 0006-5369
11-digit product format 000065369
Labeler code 0006
Product ID 0006-5369_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 2.5; 500 mg/1; mg/1
Pharmacologic classes Biguanide [EPC], Biguanides [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209806-001 SEGLUROMET ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL RLD 2017-12-19 N209806-002 SEGLUROMET ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE 2.5MG;1GM TABLET / ORAL RLD 2017-12-19 N209806-003 SEGLUROMET ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE 7.5MG;500MG TABLET / ORAL RLD 2017-12-19 N209806-004 SEGLUROMET ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE 7.5MG;1GM TABLET / ORAL RLD, RS 2017-12-19
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209806-001 9308204 2030-10-21 Drug product 2018-01-16 N209806-001 9439902 2030-10-21 U-2214 2018-01-16 N209806-001 8080580 2031-12-19 U-2214 Drug substance, Drug product 2018-01-16 N209806-002 9308204 2030-10-21 Drug product 2018-01-16 N209806-002 9439902 2030-10-21 U-2214 2018-01-16 N209806-002 8080580 2031-12-19 U-2214 Drug substance, Drug product 2018-01-16 N209806-003 9308204 2030-10-21 Drug product 2018-01-16 N209806-003 9439902 2030-10-21 U-2214 2018-01-16 N209806-003 8080580 2031-12-19 U-2214 Drug substance, Drug product 2018-01-16 N209806-004 9308204 2030-10-21 Drug product 2018-01-16 N209806-004 9439902 2030-10-21 U-2214 2018-01-16 N209806-004 8080580 2031-12-19 U-2214 Drug substance, Drug product 2018-01-16
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 5 · 168 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N209806-001 SEGLUROMET 2.5MG;500MG TABLET / ORAL RLD 2017-12-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209806-002 SEGLUROMET 2.5MG;1GM TABLET / ORAL RLD 2017-12-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209806-003 SEGLUROMET 7.5MG;500MG TABLET / ORAL RLD 2017-12-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209806-004 SEGLUROMET 7.5MG;1GM TABLET / ORAL RLD, RS 2017-12-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209806-001 SEGLUROMET 2.5MG;500MG TABLET / ORAL RLD 2017-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209806-002 SEGLUROMET 2.5MG;1GM TABLET / ORAL RLD 2017-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209806-003 SEGLUROMET 7.5MG;500MG TABLET / ORAL RLD 2017-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209806-004 SEGLUROMET 7.5MG;1GM TABLET / ORAL RLD, RS 2017-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209806-001 SEGLUROMET 2.5MG;500MG TABLET / ORAL RLD 2017-12-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209806-002 SEGLUROMET 2.5MG;1GM TABLET / ORAL RLD 2017-12-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209806-003 SEGLUROMET 7.5MG;500MG TABLET / ORAL RLD 2017-12-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209806-004 SEGLUROMET 7.5MG;1GM TABLET / ORAL RLD, RS 2017-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209806-001 SEGLUROMET 2.5MG;500MG TABLET / ORAL RLD 2017-12-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209806-002 SEGLUROMET 2.5MG;1GM TABLET / ORAL RLD 2017-12-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209806-003 SEGLUROMET 7.5MG;500MG TABLET / ORAL RLD 2017-12-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209806-004 SEGLUROMET 7.5MG;1GM TABLET / ORAL RLD, RS 2017-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209806-001 SEGLUROMET 2.5MG;500MG TABLET / ORAL RLD 2017-12-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209806-002 SEGLUROMET 2.5MG;1GM TABLET / ORAL RLD 2017-12-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209806-003 SEGLUROMET 7.5MG;500MG TABLET / ORAL RLD 2017-12-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209806-004 SEGLUROMET 7.5MG;1GM TABLET / ORAL RLD, RS 2017-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209806-001 SEGLUROMET 2.5MG;500MG TABLET / ORAL RLD 2017-12-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209806-002 SEGLUROMET 2.5MG;1GM TABLET / ORAL RLD 2017-12-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209806-003 SEGLUROMET 7.5MG;500MG TABLET / ORAL RLD 2017-12-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209806-004 SEGLUROMET 7.5MG;1GM TABLET / ORAL RLD, RS 2017-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209806-001 SEGLUROMET 2.5MG;500MG TABLET / ORAL RLD 2017-12-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209806-002 SEGLUROMET 2.5MG;1GM TABLET / ORAL RLD 2017-12-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209806-003 SEGLUROMET 7.5MG;500MG TABLET / ORAL RLD 2017-12-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209806-004 SEGLUROMET 7.5MG;1GM TABLET / ORAL RLD, RS 2017-12-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209806-001 SEGLUROMET 2.5MG;500MG TABLET / ORAL RLD 2017-12-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209806-002 SEGLUROMET 2.5MG;1GM TABLET / ORAL RLD 2017-12-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209806-003 SEGLUROMET 7.5MG;500MG TABLET / ORAL RLD 2017-12-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209806-004 SEGLUROMET 7.5MG;1GM TABLET / ORAL RLD, RS 2017-12-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209806-001 SEGLUROMET 2.5MG;500MG TABLET / ORAL RLD 2017-12-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209806-002 SEGLUROMET 2.5MG;1GM TABLET / ORAL RLD 2017-12-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209806-003 SEGLUROMET 7.5MG;500MG TABLET / ORAL RLD 2017-12-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209806-004 SEGLUROMET 7.5MG;1GM TABLET / ORAL RLD, RS 2017-12-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209806-001 SEGLUROMET 2.5MG;500MG TABLET / ORAL RLD 2017-12-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209806-002 SEGLUROMET 2.5MG;1GM TABLET / ORAL RLD 2017-12-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209806-003 SEGLUROMET 7.5MG;500MG TABLET / ORAL RLD 2017-12-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209806-004 SEGLUROMET 7.5MG;1GM TABLET / ORAL RLD, RS 2017-12-19 d8e5a09893c0…
Observed Orange Book patent history# Patent history page 1 of 13 · 504 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N209806-001 9308204 2030-10-21 Drug product 2018-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209806-001 9439902 2030-10-21 U-2214 2018-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209806-001 8080580 2031-12-19 U-2214 Drug substance, Drug product 2018-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209806-002 9308204 2030-10-21 Drug product 2018-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209806-002 9439902 2030-10-21 U-2214 2018-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209806-002 8080580 2031-12-19 U-2214 Drug substance, Drug product 2018-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209806-003 9308204 2030-10-21 Drug product 2018-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209806-003 9439902 2030-10-21 U-2214 2018-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209806-003 8080580 2031-12-19 U-2214 Drug substance, Drug product 2018-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209806-004 9308204 2030-10-21 Drug product 2018-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209806-004 9439902 2030-10-21 U-2214 2018-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209806-004 8080580 2031-12-19 U-2214 Drug substance, Drug product 2018-01-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209806-001 8080580 2030-07-13 U-2214 Drug substance, Drug product 2018-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209806-001 9308204 2030-10-21 Drug product 2018-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209806-001 9439902 2030-10-21 U-2214 2018-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209806-002 8080580 2030-07-13 U-2214 Drug substance, Drug product 2018-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209806-002 9308204 2030-10-21 Drug product 2018-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209806-002 9439902 2030-10-21 U-2214 2018-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209806-003 8080580 2030-07-13 U-2214 Drug substance, Drug product 2018-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209806-003 9308204 2030-10-21 Drug product 2018-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209806-003 9439902 2030-10-21 U-2214 2018-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209806-004 8080580 2030-07-13 U-2214 Drug substance, Drug product 2018-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209806-004 9308204 2030-10-21 Drug product 2018-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209806-004 9439902 2030-10-21 U-2214 2018-01-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209806-001 8080580 2030-07-13 U-2214 Drug substance, Drug product 2018-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209806-001 9308204 2030-10-21 Drug product 2018-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209806-001 9439902 2030-10-21 U-2214 2018-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209806-002 8080580 2030-07-13 U-2214 Drug substance, Drug product 2018-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209806-002 9308204 2030-10-21 Drug product 2018-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209806-002 9439902 2030-10-21 U-2214 2018-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209806-003 8080580 2030-07-13 U-2214 Drug substance, Drug product 2018-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209806-003 9308204 2030-10-21 Drug product 2018-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209806-003 9439902 2030-10-21 U-2214 2018-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209806-004 8080580 2030-07-13 U-2214 Drug substance, Drug product 2018-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209806-004 9308204 2030-10-21 Drug product 2018-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209806-004 9439902 2030-10-21 U-2214 2018-01-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209806-001 8080580 2030-07-13 U-2214 Drug substance, Drug product 2018-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209806-001 9308204 2030-10-21 Drug product 2018-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209806-001 9439902 2030-10-21 U-2214 2018-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209806-002 8080580 2030-07-13 U-2214 Drug substance, Drug product 2018-01-16 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product Yes
Brand name base SEGLUROMET
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ERTUGLIFLOZIN PIDOLATE 2.5 mg/1 METFORMIN HYDROCHLORIDE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 786Z46389E Internal UNII lookup MLU731K321 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1992685 Internal RxNorm lookup 1992691 Internal RxNorm lookup 1992693 Internal RxNorm lookup 1992695 Internal RxNorm lookup 1992698 Internal RxNorm lookup 1992700 Internal RxNorm lookup 1992701 Internal RxNorm lookup 1992703 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 0006-5369-03 2020-08-14 These 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 0006-5369-03 2020-08-14 These 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 0006-5369-06 2020-08-14 These 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 0006-5369-06 2020-08-14 These 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 0006-5369-07 2020-08-14 These 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 0006-5369-07 2020-08-14 These 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 0006-5369-03 2020-07-22 These 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 0006-5369-03 2020-07-22 These 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 0006-5369-06 2020-07-22 These 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 0006-5369-06 2020-07-22 These 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 0006-5369-07 2020-07-22 These 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 0006-5369-07 2020-07-22 These 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 NDC Product Description Form Quantity Strength SPL version 0006-5369-03 SEGLUROMET 60 in 1 BOTTLE TABLET, FILM COATED 60 19 0006-5369-06 SEGLUROMET 180 in 1 BOTTLE TABLET, FILM COATED 180 19 0006-5369-07 SEGLUROMET 500 in 1 BOTTLE TABLET, FILM COATED 500 19
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0006-5369 SEGLUROMET (ERTUGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME LLC] 19 Current NDC, Legacy NDC, 3 package rows 20250112_a6aeb99a-ce49-4125-90ce-642df3f1ebad.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0006-5369-03 00006536903 60 TABLET, FILM COATED in 1 BOTTLE (0006-5369-03) 2017-12-19 0000-00-00 No No Current 0006-5369-06 00006536906 180 TABLET, FILM COATED in 1 BOTTLE (0006-5369-06) 2017-12-19 0000-00-00 No No Current 0006-5369-07 00006536907 500 TABLET, FILM COATED in 1 BOTTLE (0006-5369-07) 2017-12-19 0000-00-00 No No Current