Home NDC 50090-6231 SEGLUROMET
Product NDC 50090-6231
11-digit product format 500906231
Labeler code 50090
Product ID 50090-6231_ab53fbcd-a600-406d-b6d2-ae6017d96f92
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ertugliflozin and metformin hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application NDA209806
Marketing category NDA
Marketing start 2017-12-19
Marketing end 0000-00-00
Substance ERTUGLIFLOZIN PIDOLATE; METFORMIN HYDROCHLORIDE
Active strength 8 mg/1; mg/1
Pharmacologic classes Biguanide [EPC], Biguanides [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-6231-0 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-6231-0 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50090-6231-0 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50090-6231-0 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50090-6231-0 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50090-6231-0 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50090-6231-0 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50090-6231-0 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50090-6231-0 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50090-6231-0 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50090-6231-0 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50090-6231-0 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 50090-6231-0 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 50090-6231-0 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 50090-6231-0 1332a3947898…d4bfe170f9cd…
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-6231-0 SEGLUROMET 60 in 1 BOTTLE TABLET, FILM COATED 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-6231 SEGLUROMET (ERTUGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] 3 Legacy NDC, 1 package rows 20221122_8efac46d-d6bb-483a-825d-60bba09d3c17.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 50090-6231-0 50090623100 60 TABLET, FILM COATED in 1 BOTTLE (50090-6231-0) 2022-11-17 0000-00-00 No No Current