Home NDC 0006-5367 STEGLUJAN
Product NDC 0006-5367
11-digit product format 000065367
Labeler code 0006
Product ID 0006-5367_232103cc-9755-4194-867a-8679e263905a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ertugliflozin and sitagliptin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Merck Sharp & Dohme LLC
Application NDA209805
Marketing category NDA
Marketing start 2017-12-19
Substance ERTUGLIFLOZIN PIDOLATE; SITAGLIPTIN PHOSPHATE
Active strength 5; 100 mg/1; mg/1
Pharmacologic classes Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209805-001 STEGLUJAN ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 N209805-002 STEGLUJAN ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209805-001 7326708 2026-11-24 U-2214 Drug substance, Drug product 2018-01-16 N209805-001 7326708*PED 2027-05-24 Pediatric extension N209805-001 9308204 2030-10-21 Drug product 2018-01-16 N209805-001 9439901 2030-10-21 U-2214 2018-01-16 N209805-001 8080580 2031-12-19 U-2214 Drug substance, Drug product 2018-01-16 N209805-002 7326708 2026-11-24 U-2214 Drug substance, Drug product 2018-01-16 N209805-002 7326708*PED 2027-05-24 Pediatric extension N209805-002 9308204 2030-10-21 Drug product 2018-01-16 N209805-002 9439901 2030-10-21 U-2214 2018-01-16 N209805-002 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 3 · 84 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 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209805-001 STEGLUJAN 5MG;EQ 100MG BASE TABLET / ORAL RLD 2017-12-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N209805-002 STEGLUJAN 15MG;EQ 100MG BASE TABLET / ORAL RLD, RS 2017-12-19 bb7c543d1eb4…
Observed Orange Book patent history# Patent history page 1 of 13 · 508 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 N209805-001 7326708 2026-11-24 U-2214 Drug substance, Drug product 2018-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209805-001 7326708*PED 2027-05-24 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209805-001 9308204 2030-10-21 Drug product 2018-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209805-001 9439901 2030-10-21 U-2214 2018-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209805-001 8080580 2031-12-19 U-2214 Drug substance, Drug product 2018-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209805-002 7326708 2026-11-24 U-2214 Drug substance, Drug product 2018-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209805-002 7326708*PED 2027-05-24 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209805-002 9308204 2030-10-21 Drug product 2018-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209805-002 9439901 2030-10-21 U-2214 2018-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209805-002 8080580 2031-12-19 U-2214 Drug substance, Drug product 2018-01-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209805-001 7326708 2026-11-24 U-2214 Drug substance, Drug product 2018-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209805-001 7326708*PED 2027-05-24 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209805-001 8080580 2030-07-13 U-2214 Drug substance, Drug product 2018-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209805-001 9308204 2030-10-21 Drug product 2018-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209805-001 9439901 2030-10-21 U-2214 2018-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209805-002 7326708 2026-11-24 U-2214 Drug substance, Drug product 2018-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209805-002 7326708*PED 2027-05-24 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209805-002 8080580 2030-07-13 U-2214 Drug substance, Drug product 2018-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209805-002 9308204 2030-10-21 Drug product 2018-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209805-002 9439901 2030-10-21 U-2214 2018-01-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209805-001 7326708 2026-11-24 U-2214 Drug substance, Drug product 2018-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209805-001 7326708*PED 2027-05-24 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209805-001 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 N209805-001 9308204 2030-10-21 Drug product 2018-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209805-001 9439901 2030-10-21 U-2214 2018-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209805-002 7326708 2026-11-24 U-2214 Drug substance, Drug product 2018-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209805-002 7326708*PED 2027-05-24 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209805-002 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 N209805-002 9308204 2030-10-21 Drug product 2018-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209805-002 9439901 2030-10-21 U-2214 2018-01-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209805-001 7326708 2026-11-24 U-2214 Drug substance, Drug product 2018-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209805-001 7326708*PED 2027-05-24 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209805-001 8080580 2030-07-13 U-2214 Drug substance, Drug product 2018-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209805-001 9308204 2030-10-21 Drug product 2018-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209805-001 9439901 2030-10-21 U-2214 2018-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209805-002 7326708 2026-11-24 U-2214 Drug substance, Drug product 2018-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209805-002 7326708*PED 2027-05-24 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209805-002 8080580 2030-07-13 U-2214 Drug substance, Drug product 2018-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209805-002 9308204 2030-10-21 Drug product 2018-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209805-002 9439901 2030-10-21 U-2214 2018-01-16 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base STEGLUJAN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ERTUGLIFLOZIN PIDOLATE 5 mg/1 SITAGLIPTIN PHOSPHATE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination MLU731K321 Internal UNII lookup TS63EW8X6F Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1992826 Internal RxNorm lookup 1992832 Internal RxNorm lookup 1992835 Internal RxNorm lookup 1992837 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0006-5367-03 STEGLUJAN 30 in 1 BOTTLE TABLET, FILM COATED 30 23 0006-5367-06 STEGLUJAN 90 in 1 BOTTLE TABLET, FILM COATED 90 23 0006-5367-07 STEGLUJAN 500 in 1 BOTTLE TABLET, FILM COATED 500 23 0006-5367-08 STEGLUJAN 7 in 1 BOTTLE TABLET, FILM COATED 7 23 0006-5367-09 STEGLUJAN 2 in 1 CARTON TABLET, FILM COATED 2 23
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0006-5367 STEGLUJAN (ERTUGLIFLOZIN AND SITAGLIPTIN) TABLET, FILM COATED [MERCK SHARP & DOHME LLC] 23 Current NDC, Legacy NDC, 5 package rows 20250112_c2c553d8-5a9d-4366-bf53-8bdb5a876d19.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0006-5367-03 00006536703 30 TABLET, FILM COATED in 1 BOTTLE (0006-5367-03) 2017-12-19 0000-00-00 No No Current 0006-5367-06 00006536706 90 TABLET, FILM COATED in 1 BOTTLE (0006-5367-06) 2017-12-19 0000-00-00 No No Current 0006-5367-07 00006536707 500 TABLET, FILM COATED in 1 BOTTLE (0006-5367-07) 2017-12-19 0000-00-00 No No Current 0006-5367-08 00006536708 7 in 1 BOTTLE Historical 0006-5367-09 00006536709 2 BOTTLE in 1 CARTON (0006-5367-09) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5367-08) 2 bottle 2017-12-19 0000-00-00 Yes No Current