Application 205649

Type: NDA
Sponsor: ASTRAZENECA AB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XIGDUO XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG;500MG	Yes	No
002	XIGDUO XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG;1GM	Yes	No
003	XIGDUO XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG;500MG	Yes	No
004	XIGDUO XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG;1GM	Yes	Yes
005	XIGDUO XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	2.5MG;1GM	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N205649-001	XIGDUO XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-10-29
N205649-002	XIGDUO XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-10-29
N205649-003	XIGDUO XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	10MG;500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-10-29
N205649-004	XIGDUO XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2014-10-29
N205649-005	XIGDUO XR	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-07-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N205649-001	AB
N205649-002	AB
N205649-003	AB
N205649-004	AB
N205649-005	AB

Orange Book patents#

Current patent rows page 1 of 1 · 50 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205649-001	6515117	2025-10-04	U-493	Drug substance, Drug product	2014-11-24
N205649-001	6515117*PED	2026-04-04		Pediatric extension
N205649-001	8501698	2027-06-20	U-493	Drug product	2014-11-24
N205649-001	8501698*PED	2027-12-20		Pediatric extension
N205649-001	7919598	2029-12-16		Drug substance	2014-11-24
N205649-001	8685934	2030-05-26	U-1522		2014-11-24
N205649-001	7919598*PED	2030-06-16		Pediatric extension
N205649-001	9616028	2030-11-12		Drug product	2017-08-30
N205649-001	8685934*PED	2030-11-26		Pediatric extension
N205649-001	9616028*PED	2031-05-12		Pediatric extension
N205649-002	6515117	2025-10-04	U-493	Drug substance, Drug product	2014-11-24
N205649-002	6515117*PED	2026-04-04		Pediatric extension
N205649-002	8501698	2027-06-20	U-493	Drug product	2014-11-24
N205649-002	8501698*PED	2027-12-20		Pediatric extension
N205649-002	7919598	2029-12-16		Drug substance	2014-11-24
N205649-002	8685934	2030-05-26	U-1522		2014-11-24
N205649-002	7919598*PED	2030-06-16		Pediatric extension
N205649-002	9616028	2030-11-12		Drug product	2017-08-30
N205649-002	8685934*PED	2030-11-26		Pediatric extension
N205649-002	9616028*PED	2031-05-12		Pediatric extension
N205649-003	6515117	2025-10-04	U-493	Drug substance, Drug product	2014-11-24
N205649-003	6515117*PED	2026-04-04		Pediatric extension
N205649-003	8501698	2027-06-20	U-493	Drug product	2014-11-24
N205649-003	8501698*PED	2027-12-20		Pediatric extension
N205649-003	7919598	2029-12-16		Drug substance	2014-11-24
N205649-003	8685934	2030-05-26	U-1522		2014-11-24
N205649-003	7919598*PED	2030-06-16		Pediatric extension
N205649-003	9616028	2030-11-12		Drug product	2017-08-30
N205649-003	8685934*PED	2030-11-26		Pediatric extension
N205649-003	9616028*PED	2031-05-12		Pediatric extension
N205649-004	6515117	2025-10-04	U-493	Drug substance, Drug product	2014-11-24
N205649-004	6515117*PED	2026-04-04		Pediatric extension
N205649-004	8501698	2027-06-20	U-493	Drug product	2014-11-24
N205649-004	8501698*PED	2027-12-20		Pediatric extension
N205649-004	7919598	2029-12-16		Drug substance	2014-11-24
N205649-004	8685934	2030-05-26	U-1522		2014-11-24
N205649-004	7919598*PED	2030-06-16		Pediatric extension
N205649-004	9616028	2030-11-12		Drug product	2017-08-30
N205649-004	8685934*PED	2030-11-26		Pediatric extension
N205649-004	9616028*PED	2031-05-12		Pediatric extension
N205649-005	6515117	2025-10-04	U-493	Drug substance, Drug product	2014-11-24
N205649-005	6515117*PED	2026-04-04		Pediatric extension
N205649-005	8501698	2027-06-20	U-493	Drug product	2017-08-30
N205649-005	8501698*PED	2027-12-20		Pediatric extension
N205649-005	7919598	2029-12-16		Drug substance	2017-08-30
N205649-005	8685934	2030-05-26	U-1522		2017-08-30
N205649-005	7919598*PED	2030-06-16		Pediatric extension
N205649-005	9616028	2030-11-12		Drug product	2017-08-30
N205649-005	8685934*PED	2030-11-26		Pediatric extension
N205649-005	9616028*PED	2031-05-12		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 10 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N205649-001	NPP	2027-06-12
N205649-001	PED	2027-12-12
N205649-002	NPP	2027-06-12
N205649-002	PED	2027-12-12
N205649-003	NPP	2027-06-12
N205649-003	PED	2027-12-12
N205649-004	NPP	2027-06-12
N205649-004	PED	2027-12-12
N205649-005	NPP	2027-06-12
N205649-005	PED	2027-12-12

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 6 · 210 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	N205649-001	XIGDUO XR	5MG;500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-002	XIGDUO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-003	XIGDUO XR	10MG;500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2014-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-004	XIGDUO XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2014-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-005	XIGDUO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-07-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205649-001	XIGDUO XR	5MG;500MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205649-002	XIGDUO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205649-003	XIGDUO XR	10MG;500MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205649-004	XIGDUO XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2014-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205649-005	XIGDUO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2017-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205649-001	XIGDUO XR	5MG;500MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205649-002	XIGDUO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205649-003	XIGDUO XR	10MG;500MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205649-004	XIGDUO XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2014-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205649-005	XIGDUO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2017-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205649-001	XIGDUO XR	5MG;500MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205649-002	XIGDUO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205649-003	XIGDUO XR	10MG;500MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205649-004	XIGDUO XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2014-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205649-005	XIGDUO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2017-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205649-001	XIGDUO XR	5MG;500MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205649-002	XIGDUO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205649-003	XIGDUO XR	10MG;500MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205649-004	XIGDUO XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2014-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205649-005	XIGDUO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2017-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205649-001	XIGDUO XR	5MG;500MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205649-002	XIGDUO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205649-003	XIGDUO XR	10MG;500MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205649-004	XIGDUO XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2014-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205649-005	XIGDUO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2017-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205649-001	XIGDUO XR	5MG;500MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205649-002	XIGDUO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205649-003	XIGDUO XR	10MG;500MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205649-004	XIGDUO XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2014-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205649-005	XIGDUO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2017-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205649-001	XIGDUO XR	5MG;500MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205649-002	XIGDUO XR	5MG;1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205649-003	XIGDUO XR	10MG;500MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2014-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205649-004	XIGDUO XR	10MG;1GM	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2014-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205649-005	XIGDUO XR	2.5MG;1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2017-07-28	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N205649-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-005	AB	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205649-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205649-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205649-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205649-004	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205649-005	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 38 · 1,515 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	N205649-001	6515117	2025-10-04	U-493	Drug substance, Drug product	2014-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-001	6515117*PED	2026-04-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-001	8501698	2027-06-20	U-493	Drug product	2014-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-001	8501698*PED	2027-12-20		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-001	7919598	2029-12-16		Drug substance	2014-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-001	8685934	2030-05-26	U-1522		2014-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-001	7919598*PED	2030-06-16		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-001	9616028	2030-11-12		Drug product	2017-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-001	8685934*PED	2030-11-26		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-001	9616028*PED	2031-05-12		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-002	6515117	2025-10-04	U-493	Drug substance, Drug product	2014-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-002	6515117*PED	2026-04-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-002	8501698	2027-06-20	U-493	Drug product	2014-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-002	8501698*PED	2027-12-20		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-002	7919598	2029-12-16		Drug substance	2014-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-002	8685934	2030-05-26	U-1522		2014-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-002	7919598*PED	2030-06-16		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-002	9616028	2030-11-12		Drug product	2017-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-002	8685934*PED	2030-11-26		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-002	9616028*PED	2031-05-12		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-003	6515117	2025-10-04	U-493	Drug substance, Drug product	2014-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-003	6515117*PED	2026-04-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-003	8501698	2027-06-20	U-493	Drug product	2014-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-003	8501698*PED	2027-12-20		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-003	7919598	2029-12-16		Drug substance	2014-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-003	8685934	2030-05-26	U-1522		2014-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-003	7919598*PED	2030-06-16		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-003	9616028	2030-11-12		Drug product	2017-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-003	8685934*PED	2030-11-26		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-003	9616028*PED	2031-05-12		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-004	6515117	2025-10-04	U-493	Drug substance, Drug product	2014-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-004	6515117*PED	2026-04-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-004	8501698	2027-06-20	U-493	Drug product	2014-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-004	8501698*PED	2027-12-20		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-004	7919598	2029-12-16		Drug substance	2014-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-004	8685934	2030-05-26	U-1522		2014-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-004	7919598*PED	2030-06-16		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-004	9616028	2030-11-12		Drug product	2017-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-004	8685934*PED	2030-11-26		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-004	9616028*PED	2031-05-12		Pediatric extension		`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 7 · 255 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N205649-001	NPP	2027-06-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-001	PED	2027-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-002	NPP	2027-06-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-002	PED	2027-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-003	NPP	2027-06-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-003	PED	2027-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-004	NPP	2027-06-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-004	PED	2027-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-005	NPP	2027-06-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205649-005	PED	2027-12-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205649-001	NPP	2027-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205649-001	PED	2027-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205649-002	NPP	2027-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205649-002	PED	2027-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205649-003	NPP	2027-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205649-003	PED	2027-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205649-004	NPP	2027-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205649-004	PED	2027-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205649-005	NPP	2027-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205649-005	PED	2027-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205649-001	NPP	2027-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205649-001	PED	2027-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205649-002	NPP	2027-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205649-002	PED	2027-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205649-003	NPP	2027-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205649-003	PED	2027-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205649-004	NPP	2027-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205649-004	PED	2027-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205649-005	NPP	2027-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205649-005	PED	2027-12-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205649-001	NPP	2027-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205649-001	PED	2027-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205649-002	NPP	2027-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205649-002	PED	2027-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205649-003	NPP	2027-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205649-003	PED	2027-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205649-004	NPP	2027-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205649-004	PED	2027-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205649-005	NPP	2027-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205649-005	PED	2027-12-12	`6a471c1ec25d…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XIGDUO XR	DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	2026-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 205649 application number: NDA205649 ndc (product): 0310-6260 ndc (product): 0310-6225 ndc (product): 0310-6270 ndc (product): 0310-6250 ndc (product): 0310-6280
dapagliflozin and metformin hydrochloride	DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	Prasco Laboratories	eaf135b6-e378-4f62-a1e7-db45e23668c7	2024-12-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 205649 application number: NDA205649

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 45 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0310-6225	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6225	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6225	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6225	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6225	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6225	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6225	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6225	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6225	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6250	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6250	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6250	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6250	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6250	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6250	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6250	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6250	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6250	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6260	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6260	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6260	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6260	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6260	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6260	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6260	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6260	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6260	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6270	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6270	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6270	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6270	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6270	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6270	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6270	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6270	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6270	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6280	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6280	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6280	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6280	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6280	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6280	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6280	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6280	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6280	XIGDUO	dapagliflozin and metformin hydrochloride	AstraZeneca Pharmaceuticals LP	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80707	SUPPL	2024-12-26
80700	SUPPL	2024-12-23
80699	SUPPL	2024-12-23
78791	SUPPL	2024-06-13
78790	SUPPL	2024-06-13
75426	SUPPL	2023-09-13
75413	SUPPL	2023-09-13
72372	SUPPL	2022-10-17
72371	SUPPL	2022-10-17
72328	SUPPL	2022-10-14
70761	SUPPL	2022-04-14
70760	SUPPL	2022-04-14
70752	SUPPL	2022-04-12
70102	SUPPL	2022-02-07
70101	SUPPL	2022-02-07
70092	SUPPL	2022-02-04
61775	SUPPL	2020-02-04
61772	SUPPL	2020-02-04
61771	SUPPL	2020-02-04
61689	SUPPL	2020-01-27
61684	SUPPL	2020-01-27
61683	SUPPL	2020-01-27
61661	SUPPL	2020-01-27
60617	SUPPL	2019-10-22
60601	SUPPL	2019-10-21
60600	SUPPL	2019-10-21
57821	SUPPL	2019-02-27
57802	SUPPL	2019-02-25
56195	SUPPL	2018-10-30
56147	SUPPL	2018-10-29
52234	SUPPL	2018-02-01
47461	SUPPL	2017-03-03
47393	SUPPL	2017-03-02
45093	SUPPL	2016-08-22
45051	SUPPL	2016-08-17
40493	SUPPL	2016-06-17
32701	SUPPL	2016-06-16
40492	SUPPL	2015-12-08
32700	SUPPL	2015-12-07
43498	ORIG	2015-04-06
24500	ORIG	2015-04-06
40491	ORIG	2014-11-04
10486	ORIG	2014-10-31