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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70518-2046		D	Discontinued by firm		2026-08-03
excluded package	package	70518-2046	70518-2046-0	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 2 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	70518-2046		D	Discontinued by firm		excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-2046	70518-2046-0	D	Discontinued by firm		excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

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.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206073-001	8883805	2025-11-26		Drug product	2015-02-19
N206073-001	8883805*PED	2026-05-26		Pediatric extension
N206073-001	7713938	2027-04-15		Drug substance, Drug product	2015-02-19
N206073-001	11033552	2027-05-04		Drug product	2021-07-09
N206073-001	12178819	2027-05-04		Drug product	2025-01-24
N206073-001	8673927	2027-05-04	U-1652	Delist requested	2015-02-19
N206073-001	9173859	2027-05-04	U-1772	Drug product, Delist requested	2015-12-02
N206073-001	7713938*PED	2027-10-15		Pediatric extension
N206073-001	11033552*PED	2027-11-04		Pediatric extension
N206073-001	8673927*PED	2027-11-04		Pediatric extension
N206073-001	7579449	2028-08-01		Drug substance	2015-02-19
N206073-001	7579449*PED	2029-02-01		Pediatric extension
N206073-001	8551957	2029-10-14	U-1651	Drug product	2015-02-19
N206073-001	12115179	2030-02-11	U-4023		2024-11-12
N206073-001	8551957*PED	2030-04-14		Pediatric extension
N206073-001	12115179*PED	2030-08-11		Pediatric extension
N206073-001	10258637	2034-04-03	U-2290		2019-04-30
N206073-001	11090323	2034-04-03	U-3191		2021-08-20
N206073-001	11833166	2034-04-03	U-3776		2024-01-03
N206073-001	11833166	2034-04-03	U-3777		2024-01-03
N206073-001	12433906	2034-04-03	U-4293		2025-10-29
N206073-001	12433906	2034-04-03	U-4294		2025-10-29
N206073-001	12433906	2034-04-03	U-4295		2025-10-29
N206073-001	12433906	2034-04-03	U-4296		2025-10-29
N206073-001	12433906	2034-04-03	U-4304		2025-10-29
N206073-001	9949998	2034-06-11	U-2290		2018-05-15
N206073-001	10258637*PED	2034-10-03		Pediatric extension
N206073-001	11090323*PED	2034-10-03		Pediatric extension
N206073-001	11833166*PED	2034-10-03		Pediatric extension
N206073-001	12433906*PED	2034-10-03		Pediatric extension
N206073-001	12364700	2037-06-08	U-4224		2025-07-31
N206073-001	12364700*PED	2037-12-08		Pediatric extension
N206073-002	8883805	2025-11-26		Drug product	2015-02-19
N206073-002	8883805*PED	2026-05-26		Pediatric extension
N206073-002	7713938	2027-04-15		Drug substance, Drug product	2015-02-19
N206073-002	11033552	2027-05-04		Drug product	2021-07-09
N206073-002	12178819	2027-05-04		Drug product	2025-01-24
N206073-002	8673927	2027-05-04	U-1652	Delist requested	2015-02-19
N206073-002	9173859	2027-05-04	U-1772	Drug product, Delist requested	2015-12-02
N206073-002	7713938*PED	2027-10-15		Pediatric extension
N206073-002	11033552*PED	2027-11-04		Pediatric extension
N206073-002	8673927*PED	2027-11-04		Pediatric extension
N206073-002	7579449	2028-08-01		Drug substance	2015-02-19
N206073-002	7579449*PED	2029-02-01		Pediatric extension
N206073-002	8551957	2029-10-14	U-1651	Drug product	2015-02-19
N206073-002	12115179	2030-02-11	U-4023		2024-11-12
N206073-002	8551957*PED	2030-04-14		Pediatric extension
N206073-002	12115179*PED	2030-08-11		Pediatric extension
N206073-002	10258637	2034-04-03	U-2290		2019-04-30
N206073-002	11090323	2034-04-03	U-3191		2021-08-20
N206073-002	11833166	2034-04-03	U-3776		2024-01-03
N206073-002	11833166	2034-04-03	U-3777		2024-01-03
N206073-002	12433906	2034-04-03	U-4293		2025-10-29
N206073-002	12433906	2034-04-03	U-4294		2025-10-29
N206073-002	12433906	2034-04-03	U-4295		2025-10-29
N206073-002	12433906	2034-04-03	U-4296		2025-10-29
N206073-002	12433906	2034-04-03	U-4304		2025-10-29
N206073-002	9949998	2034-06-11	U-2290		2018-05-15
N206073-002	10258637*PED	2034-10-03		Pediatric extension
N206073-002	11090323*PED	2034-10-03		Pediatric extension
N206073-002	11833166*PED	2034-10-03		Pediatric extension
N206073-002	12433906*PED	2034-10-03		Pediatric extension
N206073-002	12364700	2037-06-08	U-4224		2025-07-31
N206073-002	12364700*PED	2037-12-08		Pediatric extension

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2022-03-09 01:35 UTC	2022-03	N206073-001	GLYXAMBI	10MG;5MG	TABLET / ORAL	RLD	2015-01-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206073-002	GLYXAMBI	25MG;5MG	TABLET / ORAL	RLD, RS	2015-01-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206073-001	GLYXAMBI	10MG;5MG	TABLET / ORAL	RLD	2015-01-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206073-002	GLYXAMBI	25MG;5MG	TABLET / ORAL	RLD, RS	2015-01-30	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 40 · 1,570 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206073-001	8883805	2025-11-26		Drug product	2015-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	8883805*PED	2026-05-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	7713938	2027-04-15		Drug substance, Drug product	2015-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	11033552	2027-05-04		Drug product	2021-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	12178819	2027-05-04		Drug product	2025-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	8673927	2027-05-04	U-1652	Delist requested	2015-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	9173859	2027-05-04	U-1772	Drug product, Delist requested	2015-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	7713938*PED	2027-10-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	11033552*PED	2027-11-04		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	8673927*PED	2027-11-04		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	7579449	2028-08-01		Drug substance	2015-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	7579449*PED	2029-02-01		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	8551957	2029-10-14	U-1651	Drug product	2015-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	12115179	2030-02-11	U-4023		2024-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	8551957*PED	2030-04-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	12115179*PED	2030-08-11		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	10258637	2034-04-03	U-2290		2019-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	11090323	2034-04-03	U-3191		2021-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	11833166	2034-04-03	U-3776		2024-01-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	11833166	2034-04-03	U-3777		2024-01-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	12433906	2034-04-03	U-4304		2025-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	12433906	2034-04-03	U-4293		2025-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	12433906	2034-04-03	U-4294		2025-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	12433906	2034-04-03	U-4295		2025-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	12433906	2034-04-03	U-4296		2025-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	9949998	2034-06-11	U-2290		2018-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	10258637*PED	2034-10-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	11090323*PED	2034-10-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	11833166*PED	2034-10-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	12433906*PED	2034-10-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	12364700	2037-06-08	U-4224		2025-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-001	12364700*PED	2037-12-08		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-002	8883805	2025-11-26		Drug product	2015-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-002	8883805*PED	2026-05-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-002	7713938	2027-04-15		Drug substance, Drug product	2015-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-002	11033552	2027-05-04		Drug product	2021-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-002	12178819	2027-05-04		Drug product	2025-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-002	8673927	2027-05-04	U-1652	Delist requested	2015-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-002	9173859	2027-05-04	U-1772	Drug product, Delist requested	2015-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206073-002	7713938*PED	2027-10-15		Pediatric extension		`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206073-001	M-258	2022-07-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206073-001	M-252	2023-03-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206073-002	M-258	2022-07-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206073-002	M-252	2023-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206073-001	M-258	2022-07-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206073-001	M-252	2023-03-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206073-002	M-258	2022-07-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206073-002	M-252	2023-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206073-001	M-258	2022-07-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206073-001	M-252	2023-03-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206073-002	M-258	2022-07-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206073-002	M-252	2023-03-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206073-001	NCE	2019-08-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206073-001	I-739	2019-12-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206073-002	NCE	2019-08-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206073-002	I-739	2019-12-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206073-001	M-258	2022-07-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206073-001	M-252	2023-03-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206073-002	M-258	2022-07-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206073-002	M-252	2023-03-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206073-001	M-258	2022-07-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206073-001	M-252	2023-03-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206073-002	M-258	2022-07-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206073-002	M-252	2023-03-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206073-001	M-258	2022-07-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206073-001	M-252	2023-03-30	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206073-002	M-258	2022-07-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206073-002	M-252	2023-03-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206073-001	M-258	2022-07-03	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N206073-001	M-252	2023-03-30	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N206073-002	M-258	2022-07-03	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N206073-002	M-252	2023-03-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206073-001	M-258	2022-07-03	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N206073-001	M-252	2023-03-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N206073-002	M-258	2022-07-03	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N206073-002	M-252	2023-03-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206073-001	M-258	2022-07-03	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N206073-001	M-252	2023-03-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N206073-002	M-258	2022-07-03	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N206073-002	M-252	2023-03-30	`c0c555d07b60…`

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.

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HDC1R2M35U	EMPAGLIFLOZIN	864070-44-0	EMPAGLIFLOZIN
3X29ZEJ4R2	LINAGLIPTIN	668270-12-0	LINAGLIPTIN