Home NDC 0597-0182-07 Glyxambi
Product NDC 0597-0182
Requested package NDC 0597-0182-07
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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.
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 2026-08-01 22:54:32 2026-06 N206073-001 GLYXAMBI 10MG;5MG TABLET / ORAL RLD 2015-01-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-002 GLYXAMBI 25MG;5MG TABLET / ORAL RLD, RS 2015-01-30 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 64 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N206073-001 8883805 2025-11-26 Drug product 2015-02-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 8883805*PED 2026-05-26 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 7713938 2027-04-15 Drug substance, Drug product 2015-02-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 11033552 2027-05-04 Drug product 2021-07-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 12178819 2027-05-04 Drug product 2025-01-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 8673927 2027-05-04 U-1652 Delist requested 2015-02-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 9173859 2027-05-04 U-1772 Drug product, Delist requested 2015-12-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 7713938*PED 2027-10-15 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 11033552*PED 2027-11-04 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 8673927*PED 2027-11-04 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 7579449 2028-08-01 Drug substance 2015-02-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 7579449*PED 2029-02-01 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 8551957 2029-10-14 U-1651 Drug product 2015-02-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 12115179 2030-02-11 U-4023 2024-11-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 8551957*PED 2030-04-14 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 12115179*PED 2030-08-11 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 10258637 2034-04-03 U-2290 2019-04-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 11090323 2034-04-03 U-3191 2021-08-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 11833166 2034-04-03 U-3776 2024-01-03 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 11833166 2034-04-03 U-3777 2024-01-03 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 12433906 2034-04-03 U-4304 2025-10-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 12433906 2034-04-03 U-4293 2025-10-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 12433906 2034-04-03 U-4294 2025-10-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 12433906 2034-04-03 U-4295 2025-10-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 12433906 2034-04-03 U-4296 2025-10-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 9949998 2034-06-11 U-2290 2018-05-15 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 10258637*PED 2034-10-03 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 11090323*PED 2034-10-03 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 11833166*PED 2034-10-03 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 12433906*PED 2034-10-03 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 12364700 2037-06-08 U-4224 2025-07-31 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-001 12364700*PED 2037-12-08 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-002 8883805 2025-11-26 Drug product 2015-02-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-002 8883805*PED 2026-05-26 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-002 7713938 2027-04-15 Drug substance, Drug product 2015-02-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-002 11033552 2027-05-04 Drug product 2021-07-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-002 12178819 2027-05-04 Drug product 2025-01-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-002 8673927 2027-05-04 U-1652 Delist requested 2015-02-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-002 9173859 2027-05-04 U-1772 Drug product, Delist requested 2015-12-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N206073-002 7713938*PED 2027-10-15 Pediatric extension a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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 HDC1R2M35U Internal UNII lookup 3X29ZEJ4R2 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
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 0597-0182-07 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