Home NDC 70518-2046 Glyxambi
Product NDC 70518-2046
11-digit product format 705182046
Labeler code 70518
Product ID 70518-2046_b947aa89-b45f-6e4d-e053-2995a90abb38
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name empagliflozin and linagliptin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application NDA206073
Marketing category NDA
Marketing start 2019-04-29
Marketing end 0000-00-00
Substance EMPAGLIFLOZIN; LINAGLIPTIN
Active strength 10 mg/1; mg/1
Pharmacologic classes Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
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 · 24 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 70518-2046-0 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 70518-2046-0 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 70518-2046-0 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 70518-2046-0 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 70518-2046-0 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 70518-2046-0 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 70518-2046-0 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 70518-2046-0 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 70518-2046-0 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 70518-2046-0 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 70518-2046-0 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 70518-2046-0 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N206073-001 GLYXAMBI EMPAGLIFLOZIN; LINAGLIPTIN 10MG;5MG TABLET / ORAL RLD 2015-01-30 N206073-002 GLYXAMBI EMPAGLIFLOZIN; LINAGLIPTIN 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30
Orange Book patents# Current patent rows page 1 of 1 · 64 matching rows.
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 · 86 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 2026-09-14 22:38:34 2026-08 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 74a2ff9319b5…
Observed Orange Book patent history# Patent history page 1 of 43 · 1,698 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N206073-001 8883805 2025-11-26 Drug product 2015-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 8883805*PED 2026-05-26 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 7713938 2027-04-15 Drug substance, Drug product 2015-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 11033552 2027-05-04 Drug product 2021-07-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 12178819 2027-05-04 Drug product 2025-01-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 8673927 2027-05-04 U-1652 Delist requested 2015-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 9173859 2027-05-04 U-1772 Drug product, Delist requested 2015-12-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 7713938*PED 2027-10-15 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 11033552*PED 2027-11-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 8673927*PED 2027-11-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 7579449 2028-08-01 Drug substance 2015-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 7579449*PED 2029-02-01 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 8551957 2029-10-14 U-1651 Drug product 2015-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 12115179 2030-02-11 U-4023 2024-11-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 8551957*PED 2030-04-14 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 12115179*PED 2030-08-11 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 10258637 2034-04-03 U-2290 2019-04-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 11090323 2034-04-03 U-3191 2021-08-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 11833166 2034-04-03 U-3776 2024-01-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 11833166 2034-04-03 U-3777 2024-01-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 12433906 2034-04-03 U-4304 2025-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 12433906 2034-04-03 U-4293 2025-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 12433906 2034-04-03 U-4294 2025-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 12433906 2034-04-03 U-4295 2025-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 12433906 2034-04-03 U-4296 2025-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 9949998 2034-06-11 U-2290 2018-05-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 10258637*PED 2034-10-03 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 11090323*PED 2034-10-03 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 11833166*PED 2034-10-03 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 12433906*PED 2034-10-03 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 12364700 2037-06-08 U-4224 2025-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-001 12364700*PED 2037-12-08 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-002 8883805 2025-11-26 Drug product 2015-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-002 8883805*PED 2026-05-26 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-002 7713938 2027-04-15 Drug substance, Drug product 2015-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-002 11033552 2027-05-04 Drug product 2021-07-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-002 12178819 2027-05-04 Drug product 2025-01-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-002 8673927 2027-05-04 U-1652 Delist requested 2015-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-002 9173859 2027-05-04 U-1772 Drug product, Delist requested 2015-12-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206073-002 7713938*PED 2027-10-15 Pediatric extension 84e616aacf4f…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 84 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Glyxambi EMPAGLIFLOZIN AND LINAGLIPTIN Boehringer Ingelheim Pharmaceuticals, Inc. ddbab689-f76c-488c-9613-4168d41dd730 2026-01-20 Warnings, Adverse reactions Exact identifier application applno (NDA): 206073 application number: NDA206073