Home NDC 0597-0182 Glyxambi
Product NDC 0597-0182
11-digit product format 005970182
Labeler code 0597
Product ID 0597-0182_16f275d5-7526-4e7a-8776-665a9a6ae37a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name empagliflozin and linagliptin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Boehringer Ingelheim Pharmaceuticals, Inc.
Application NDA206073
Marketing category NDA
Marketing start 2015-01-30
Substance EMPAGLIFLOZIN; LINAGLIPTIN
Active strength 10; 5 mg/1; mg/1
Pharmacologic classes Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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.
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.
Additional Listing Data#
Finished product Yes
Brand name base Glyxambi
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EMPAGLIFLOZIN 10 mg/1 LINAGLIPTIN 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3X29ZEJ4R2 Internal UNII lookup HDC1R2M35U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1602109 Internal RxNorm lookup 1602115 Internal RxNorm lookup 1602118 Internal RxNorm lookup 1602120 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 0597-0182-03 Glyxambi 30 in 1 BOTTLE TABLET, FILM COATED 30 23 0597-0182-07 Glyxambi 7 in 1 BOTTLE TABLET, FILM COATED 7 23 0597-0182-07 Glyxambi 1 in 1 CARTON TABLET, FILM COATED 1 23 0597-0182-30 Glyxambi 30 in 1 BOTTLE TABLET, FILM COATED 30 23 0597-0182-39 Glyxambi 1 in 1 BLISTER PACK TABLET, FILM COATED 1 23 0597-0182-39 Glyxambi 30 in 1 CARTON TABLET, FILM COATED 30 23 0597-0182-70 Glyxambi 1 in 1 BLISTER PACK TABLET, FILM COATED 1 23 0597-0182-70 Glyxambi 7 in 1 CARTON TABLET, FILM COATED 7 23 0597-0182-90 Glyxambi 90 in 1 BOTTLE TABLET, FILM COATED 90 23
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded empagliflozin ACTIVE INGREDIENT HDC1R2M35U GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 2 linagliptin ACTIVE INGREDIENT 3X29ZEJ4R2 GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 2 empagliflozin ACTIVE MOIETY HDC1R2M35U GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 2 linagliptin ACTIVE MOIETY 3X29ZEJ4R2 GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 2 copovidone INACTIVE INGREDIENT D9C330MD8B GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 2 crospovidone INACTIVE INGREDIENT 68401960MK GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 2 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 2 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 2 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 2 magnesium stearate INACTIVE INGREDIENT 70097M6I30 GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 2 mannitol INACTIVE INGREDIENT 3OWL53L36A GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 2 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 2 starch, corn INACTIVE INGREDIENT O8232NY3SJ GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 2 talc INACTIVE INGREDIENT 7SEV7J4R1U GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 2 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0597-0182 GLYXAMBI (EMPAGLIFLOZIN AND LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 21 Current NDC, Legacy NDC, 9 package rows 20240713_ddbab689-f76c-488c-9613-4168d41dd730.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.
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 ndc (product): 0597-0182
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 0597-0182-03 00597018203 30 in 1 BOTTLE Historical 0597-0182-07 00597018207 1 BOTTLE in 1 CARTON (0597-0182-07) > 7 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2015-01-30 0000-00-00 No No Current 0597-0182-30 00597018230 30 TABLET, FILM COATED in 1 BOTTLE (0597-0182-30) 2015-01-30 0000-00-00 No No Current 0597-0182-39 00597018239 30 BLISTER PACK in 1 CARTON (0597-0182-39) / 1 TABLET, FILM COATED in 1 BLISTER PACK 30 blister pack 2015-01-30 0000-00-00 No No Current 0597-0182-70 00597018270 1 in 1 BLISTER PACK Historical 0597-0182-90 00597018290 90 TABLET, FILM COATED in 1 BOTTLE (0597-0182-90) 2015-01-30 0000-00-00 No No Current