XIGDUO

Product NDC: 0310-6270
11-digit product format: 003106270
Labeler code: 0310
Product ID: 0310-6270_a8717b28-9445-4292-9ac7-e979f378d9c8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dapagliflozin and metformin hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: AstraZeneca Pharmaceuticals LP
Application: NDA205649
Marketing category: NDA
Marketing start: 2014-10-29
Substance: DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE
Active strength: 10; 500 mg/1; mg/1
Pharmacologic classes: Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0310-6270	0310-6270-95	D	Discontinued by firm		2026-08-17

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: XIGDUO
Brand name suffix: XR
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DAPAGLIFLOZIN PROPANEDIOL	10 mg/1
METFORMIN HYDROCHLORIDE	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
887K2391VH	Internal UNII lookup
786Z46389E	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ac8a0f7b-9f69-4495-abbc-3a47cd75a859	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6a29d87d-f465-752d-5fa9-bd728c608ca2	Product name	4	20251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698e	Product name	1	20250724
a985afd1-89a8-bfab-0231-b59db1a3a9b5	Product name	7	20250515
25bfaa4d-02a1-402c-96ec-9bf6e625484c	Product name	1	20250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0	Product name	2	20240829
16dbe107-66d5-47b3-57ed-0cba6a8dfccc	Product name	6	20240215
08b3e508-8c7e-3b95-0275-113510642fc6	Product name	2	20220309
c30aab5e-c89f-4b59-83b1-99a940b63351	Product name	1	20200925
3a90349e-ff2e-41bd-a106-b368fbc1c1f8	Product name	1	20200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86	Product name	1	20200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5	Product name	1	20190731
85b4e38c-4488-4e48-919e-244e107d9bd9	Product name	2	20190731
ca3f036c-6c06-b829-b379-1a3a4097099c	Product name	9	20180605
e1ede89f-54c8-428f-ae84-9e8a2deb67db	Product name	1	20180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52c	Product name	2	20170824
bea938a6-c880-985b-d27b-b59b0d8b5a77	Product name	3	20170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2f	Product name	1	20170616
e2382c7e-9e14-4196-aeff-98e2cfaf63cb	Product name	1	20170224
988f737f-e7e9-4613-8558-824b1ab755f9	Product name	1	20161128
58b66776-50d5-434f-916f-958ccf131e0e	Product name	1	20160713
3e9b6ece-066b-2ac3-28f7-5e13060e5934	Product name	2	20151109
2988466d-5fc4-4430-9cee-fc9132f02d2c	Product name	1	20150910
85cbb42f-1a8d-f945-f85e-188e823b7f5b	Product name	2	20150731
e740bf83-275a-4f0c-adf4-ec60ebd882b7	Product name	1	20150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0	Product name	1	20141205
0d79b284-47e8-e90c-f249-892b9b251003	Product name	1	20140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6	Product name	1	20140508
2de6e143-c970-2061-1b77-61c3aa8f4026	Product name	1	20140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776a	Product name	1	20140508
ce63c1f8-ba50-8a17-9290-94522d75daff	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0310-6270-30	XIGDUOXR	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	30	38
0310-6270-95	XIGDUOXR	7 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	7	38
0310-6270-95	XIGDUOXR	1 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	1	38

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0310-6270-30	EA - Each	0310-6270	2dbbe4c6-ff08-4d84-aa45-f0d73d06e7b5	1	2014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DAPAGLIFLOZIN PROPANEDIOL	ACTIVE INGREDIENT	887K2391VH	XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]	1
METFORMIN HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]	1
dapagliflozin	ACTIVE MOIETY	1ULL0QJ8UC	XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]	1
metformin	ACTIVE MOIETY	9100L32L2N	XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]	1
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]	1
carboxymethylcellulose sodium	INACTIVE INGREDIENT	K679OBS311	XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]	1
crospovidone	INACTIVE INGREDIENT	68401960MK	XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]	1
HYPROMELLOSE 2208 (100000 MPA.S)	INACTIVE INGREDIENT	VM7F0B23ZI	XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]	1
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0310-6270	XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]	38	Current NDC, Legacy NDC, 3 package rows	20250123_ac8a0f7b-9f69-4495-abbc-3a47cd75a859.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 · 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): 0310-6270
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
887K2391VH	DAPAGLIFLOZIN PROPANEDIOL	960404-48-2	DAPAGLIFLOZIN PROPANEDIOL
786Z46389E	METFORMIN HYDROCHLORIDE	1115-70-4	METFORMIN HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1593058	dapagliflozin 10 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet	PSN	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1593068	dapagliflozin 10 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1940496	dapagliflozin 2.5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet	PSN	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1593070	dapagliflozin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet	PSN	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1593072	dapagliflozin 5 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet	PSN	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1593775	Xigduo XR 10/1000 24HR Extended Release Oral Tablet	PSN	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1593835	Xigduo XR 10/500 24HR Extended Release Oral Tablet	PSN	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1940498	Xigduo XR 2.5/1000 24HR Extended Release Oral Tablet	PSN	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1593833	Xigduo XR 5/1000 24HR Extended Release Oral Tablet	PSN	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1593831	Xigduo XR 5/500 24HR Extended Release Oral Tablet	PSN	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1593775	24 HR dapagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Xigduo]	SBD	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1593835	24 HR dapagliflozin 10 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet [Xigduo]	SBD	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1940498	24 HR dapagliflozin 2.5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Xigduo]	SBD	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1593833	24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Xigduo]	SBD	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1593831	24 HR dapagliflozin 5 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet [Xigduo]	SBD	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1593058	24 HR dapagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet	SCD	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1593068	24 HR dapagliflozin 10 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1940496	24 HR dapagliflozin 2.5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet	SCD	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1593070	24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet	SCD	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1593072	24 HR dapagliflozin 5 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet	SCD	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1593058	dapagliflozin (as dapagliflozin propanediol) 10 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral Tablet	SY	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1593070	dapagliflozin (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral Tablet	SY	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1593068	dapagliflozin 10 MG / metformin HCl 500 MG 24HR Extended Release Oral Tablet	SY	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1940496	dapagliflozin 2.5 MG / metformin HCl 1000 MG 24HR Extended Release Oral Tablet	SY	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1593072	dapagliflozin 5 MG / metformin HCl 500 MG 24HR Extended Release Oral Tablet	SY	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1593775	Xigduo XR 10/1000 24HR Extended Release Oral Tablet	SY	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1593835	Xigduo XR 10/500 24HR Extended Release Oral Tablet	SY	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1940498	Xigduo XR 2.5/1000 24HR Extended Release Oral Tablet	SY	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1593833	Xigduo XR 5/1000 24HR Extended Release Oral Tablet	SY	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38
1593831	Xigduo XR 5/500 24HR Extended Release Oral Tablet	SY	ac8a0f7b-9f69-4495-abbc-3a47cd75a859	38

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0310-6270-30	00310627030	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6270-30)		2014-11-11	0000-00-00	No	No	Current
0310-6270-95	00310627095	1 BLISTER PACK in 1 CARTON (0310-6270-95) > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	1 blister pack	2014-11-11	0000-00-00	Yes	No	Current