FARXIGA

Product NDC: 0310-6205
11-digit product format: 003106205
Labeler code: 0310
Product ID: 0310-6205_6ae68943-041a-4236-8f49-fb8f0edc38cf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DAPAGLIFLOZIN
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AstraZeneca Pharmaceuticals LP
Application: NDA202293
Marketing category: NDA
Marketing start: 2008-01-14
Substance: DAPAGLIFLOZIN PROPANEDIOL
Active strength: 5 mg/1
Pharmacologic classes: 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 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N202293-001	FARXIGA	DAPAGLIFLOZIN	5MG	TABLET / ORAL	AB	RLD	2014-01-08
N202293-002	FARXIGA	DAPAGLIFLOZIN	10MG	TABLET / ORAL	AB	RLD, RS	2014-01-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N202293-001	AB
N202293-002	AB

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
N202293-001	6515117	2025-10-04	U-2139	Drug substance, Drug product	2014-02-05
N202293-001	6515117	2025-10-04	U-493	Drug substance, Drug product	2014-02-05
N202293-001	6515117*PED	2026-04-04		Pediatric extension
N202293-001	8329648	2026-08-18	U-2139		2017-11-15
N202293-001	8329648	2026-08-18	U-2212		2017-11-15
N202293-001	8329648	2026-08-18	U-2213		2017-11-15
N202293-001	8906851	2026-08-18	U-2139		2017-11-15
N202293-001	8329648*PED	2027-02-18		Pediatric extension
N202293-001	8906851*PED	2027-02-18		Pediatric extension
N202293-001	8501698	2027-06-20	U-493	Drug product	2014-02-05
N202293-001	8501698*PED	2027-12-20		Pediatric extension
N202293-001	8221786	2028-03-21		Drug product	2014-02-05
N202293-001	8361972	2028-03-21	U-2139		2014-02-05
N202293-001	8361972	2028-03-21	U-493		2014-02-05
N202293-001	8716251	2028-03-21		Drug product	2014-06-02
N202293-001	7851502	2028-08-19		Drug product	2014-02-05
N202293-001	8221786*PED	2028-09-21		Pediatric extension
N202293-001	8361972*PED	2028-09-21		Pediatric extension
N202293-001	8716251*PED	2028-09-21		Pediatric extension
N202293-001	7851502*PED	2029-02-19		Pediatric extension
N202293-001	7919598	2029-12-16		Drug substance	2014-02-05
N202293-001	8721615	2030-01-18		Drug product, Delist requested	2017-11-15
N202293-001	8685934	2030-05-26	U-1522		2014-06-25
N202293-001	7919598*PED	2030-06-16		Pediatric extension
N202293-001	8721615*PED	2030-07-18		Pediatric extension
N202293-001	8685934*PED	2030-11-26		Pediatric extension
N202293-002	6515117	2025-10-04	U-2139	Drug substance, Drug product	2014-02-05
N202293-002	6515117	2025-10-04	U-493	Drug substance, Drug product	2014-02-05
N202293-002	6515117*PED	2026-04-04		Pediatric extension
N202293-002	8329648	2026-08-18	U-2139		2017-11-15
N202293-002	8329648	2026-08-18	U-2212		2017-11-15
N202293-002	8329648	2026-08-18	U-2213		2017-11-15
N202293-002	8906851	2026-08-18	U-2139		2017-11-15
N202293-002	8329648*PED	2027-02-18		Pediatric extension
N202293-002	8906851*PED	2027-02-18		Pediatric extension
N202293-002	8501698	2027-06-20	U-493	Drug product	2014-02-05
N202293-002	8501698*PED	2027-12-20		Pediatric extension
N202293-002	8221786	2028-03-21		Drug product	2014-02-05
N202293-002	8361972	2028-03-21	U-2139		2014-02-05
N202293-002	8361972	2028-03-21	U-493		2014-02-05
N202293-002	8716251	2028-03-21		Drug product	2014-06-02
N202293-002	7851502	2028-08-19		Drug product	2014-02-05
N202293-002	8221786*PED	2028-09-21		Pediatric extension
N202293-002	8361972*PED	2028-09-21		Pediatric extension
N202293-002	8716251*PED	2028-09-21		Pediatric extension
N202293-002	7851502*PED	2029-02-19		Pediatric extension
N202293-002	7919598	2029-12-16		Drug substance	2014-02-05
N202293-002	8721615	2030-01-18		Drug product, Delist requested	2017-11-15
N202293-002	8685934	2030-05-26	U-1522		2014-06-25
N202293-002	7919598*PED	2030-06-16		Pediatric extension
N202293-002	8721615*PED	2030-07-18		Pediatric extension
N202293-002	8685934*PED	2030-11-26		Pediatric extension
N202293-002	11826376	2039-07-18	U-3766		2023-12-19
N202293-002	12472194	2039-07-18	U-4346		2025-12-11
N202293-002	11826376*PED	2040-01-18		Pediatric extension
N202293-002	12472194*PED	2040-01-18		Pediatric extension
N202293-002	10973836	2040-03-09	U-3127		2021-04-21
N202293-002	11903955	2040-03-09	U-3825		2024-03-13
N202293-002	10973836*PED	2040-09-09		Pediatric extension
N202293-002	11903955*PED	2040-09-09		Pediatric extension
N202293-002	12213988	2041-04-01	U-4140		2025-03-04
N202293-002	12409186	2041-04-01	U-4140		2025-09-29
N202293-002	12213988*PED	2041-10-01		Pediatric extension
N202293-002	12409186*PED	2041-10-01		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 8 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N202293-001	M-298	2026-05-08
N202293-001	PED	2026-11-08
N202293-001	NPP	2027-06-12
N202293-001	PED	2027-12-12
N202293-002	M-298	2026-05-08
N202293-002	PED	2026-11-08
N202293-002	NPP	2027-06-12
N202293-002	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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N202293-001	FARXIGA	5MG	TABLET / ORAL	AB	RLD	2014-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-002	FARXIGA	10MG	TABLET / ORAL	AB	RLD, RS	2014-01-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202293-001	FARXIGA	5MG	TABLET / ORAL	AB	RLD	2014-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	FARXIGA	10MG	TABLET / ORAL	AB	RLD, RS	2014-01-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202293-001	FARXIGA	5MG	TABLET / ORAL	AB	RLD	2014-01-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202293-002	FARXIGA	10MG	TABLET / ORAL	AB	RLD, RS	2014-01-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202293-001	FARXIGA	5MG	TABLET / ORAL	AB	RLD	2014-01-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202293-002	FARXIGA	10MG	TABLET / ORAL	AB	RLD, RS	2014-01-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202293-001	FARXIGA	5MG	TABLET / ORAL	AB	RLD	2014-01-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202293-002	FARXIGA	10MG	TABLET / ORAL	AB	RLD, RS	2014-01-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N202293-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202293-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	AB	1	`caaa826d4ba7…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202293-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202293-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202293-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202293-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202293-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202293-002	AB	1	`4b0b4de00fa7…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202293-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202293-002	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202293-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202293-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 56 · 2,226 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N202293-001	6515117	2025-10-04	U-493	Drug substance, Drug product	2014-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-001	6515117	2025-10-04	U-2139	Drug substance, Drug product	2014-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-001	6515117*PED	2026-04-04		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-001	8329648	2026-08-18	U-2213		2017-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-001	8329648	2026-08-18	U-2139		2017-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-001	8329648	2026-08-18	U-2212		2017-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-001	8906851	2026-08-18	U-2139		2017-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-001	8329648*PED	2027-02-18		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-001	8906851*PED	2027-02-18		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-001	8501698	2027-06-20	U-493	Drug product	2014-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-001	8501698*PED	2027-12-20		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-001	8221786	2028-03-21		Drug product	2014-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-001	8361972	2028-03-21	U-2139		2014-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-001	8361972	2028-03-21	U-493		2014-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-001	8716251	2028-03-21		Drug product	2014-06-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-001	7851502	2028-08-19		Drug product	2014-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-001	8221786*PED	2028-09-21		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-001	8361972*PED	2028-09-21		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-001	8716251*PED	2028-09-21		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-001	7851502*PED	2029-02-19		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-001	7919598	2029-12-16		Drug substance	2014-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-001	8721615	2030-01-18		Drug product, Delist requested	2017-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-001	8685934	2030-05-26	U-1522		2014-06-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-001	7919598*PED	2030-06-16		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-001	8721615*PED	2030-07-18		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-001	8685934*PED	2030-11-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-002	6515117	2025-10-04	U-2139	Drug substance, Drug product	2014-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-002	6515117	2025-10-04	U-493	Drug substance, Drug product	2014-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-002	6515117*PED	2026-04-04		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-002	8329648	2026-08-18	U-2139		2017-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-002	8329648	2026-08-18	U-2212		2017-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-002	8329648	2026-08-18	U-2213		2017-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-002	8906851	2026-08-18	U-2139		2017-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-002	8329648*PED	2027-02-18		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-002	8906851*PED	2027-02-18		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-002	8501698	2027-06-20	U-493	Drug product	2014-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-002	8501698*PED	2027-12-20		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-002	8221786	2028-03-21		Drug product	2014-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-002	8361972	2028-03-21	U-2139		2014-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-002	8361972	2028-03-21	U-493		2014-02-05	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 8 · 314 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N202293-001	M-298	2026-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-001	PED	2026-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-001	NPP	2027-06-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-001	PED	2027-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-002	M-298	2026-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-002	PED	2026-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-002	NPP	2027-06-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202293-002	PED	2027-12-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202293-001	M-298	2026-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	PED	2026-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	NPP	2027-06-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	PED	2027-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	M-298	2026-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	PED	2026-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	NPP	2027-06-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	PED	2027-12-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202293-001	M-298	2026-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202293-001	PED	2026-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202293-001	NPP	2027-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202293-001	PED	2027-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202293-002	M-298	2026-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202293-002	PED	2026-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202293-002	NPP	2027-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202293-002	PED	2027-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202293-001	M-298	2026-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202293-001	PED	2026-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202293-001	NPP	2027-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202293-001	PED	2027-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202293-002	M-298	2026-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202293-002	PED	2026-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202293-002	NPP	2027-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202293-002	PED	2027-12-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202293-001	M-298	2026-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202293-001	PED	2026-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202293-001	NPP	2027-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202293-001	PED	2027-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202293-002	M-298	2026-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202293-002	PED	2026-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202293-002	NPP	2027-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202293-002	PED	2027-12-12	`6a471c1ec25d…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: FARXIGA
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DAPAGLIFLOZIN PROPANEDIOL	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1486977	Internal RxNorm lookup
1486981	Internal RxNorm lookup
1488569	Internal RxNorm lookup
1488574	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
72ad22ae-efe6-4cd6-a302-98aaee423d69	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c30aab5e-c89f-4b59-83b1-99a940b63351	Product name	1	20200925
1dc427fa-8c3b-4309-981e-ea1ff01326e5	Product name	1	20190731
85b4e38c-4488-4e48-919e-244e107d9bd9	Product name	2	20190731
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52c	Product name	2	20170824

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0310-6205-30	FARXIGA	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	45
0310-6205-90	FARXIGA	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	45
0310-6205-95	FARXIGA	1 in 1 CARTON	TABLET, FILM COATED	1	45
0310-6205-95	FARXIGA	7 in 1 BLISTER PACK	TABLET, FILM COATED	7	45

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0310-6205-30	EA - Each	0310-6205	7e7b71cc-c339-4427-8638-1fa97b1bb75c	1	2015-03-03
0310-6205-90	EA - Each	0310-6205	1bf111c2-0143-4476-8e88-46a5d9ae2ded	1	2024-05-16
0310-6205-95	EA - Each	0310-6205	36a2582f-3f30-47b6-b46d-9591924825e0	1	2021-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DAPAGLIFLOZIN PROPANEDIOL	ACTIVE INGREDIENT	887K2391VH	FARXIGA (DAPAGLIFLOZIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	3
dapagliflozin	ACTIVE MOIETY	1ULL0QJ8UC	FARXIGA (DAPAGLIFLOZIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	3
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	FARXIGA (DAPAGLIFLOZIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	3
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	FARXIGA (DAPAGLIFLOZIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	3
crospovidone	INACTIVE INGREDIENT	68401960MK	FARXIGA (DAPAGLIFLOZIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	3
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	FARXIGA (DAPAGLIFLOZIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	3
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	FARXIGA (DAPAGLIFLOZIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0310-6205	FARXIGA (DAPAGLIFLOZIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	43	Current NDC, Legacy NDC, 4 package rows	20241031_72ad22ae-efe6-4cd6-a302-98aaee423d69.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FARXIGA	DAPAGLIFLOZIN	A-S Medication Solutions	01f90c94-71cb-4a1f-81ff-8004b850529b	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202293 application number: NDA202293
DAPAGLIFLOZIN	DAPAGLIFLOZIN	Prasco Laboratories	3aba33aa-f8c6-4b10-85c8-dfa14578d07c	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202293 application number: NDA202293
FARXIGA	DAPAGLIFLOZIN	AstraZeneca Pharmaceuticals LP	72ad22ae-efe6-4cd6-a302-98aaee423d69	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202293 application number: NDA202293 ndc (product): 0310-6205
DAPAGLIFLOZIN	DAPAGLIFLOZIN	Bryant Ranch Prepack	979205ee-b0b8-4483-ae61-f283f750bb7f	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202293 application number: NDA202293
DAPAGLIFLOZIN	DAPAGLIFLOZIN	A-S Medication Solutions	82cdd5ad-df2b-4bdd-a3a6-a059040100b4	2024-06-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202293 application number: NDA202293
DAPAGLIFLOZIN	DAPAGLIFLOZIN	A-S Medication Solutions	87521963-0d2a-4a2a-89c6-d50e8582419e	2024-06-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202293 application number: NDA202293

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
887K2391VH	DAPAGLIFLOZIN PROPANEDIOL	960404-48-2	DAPAGLIFLOZIN PROPANEDIOL
1ULL0QJ8UC	DAPAGLIFLOZIN	461432-26-8	DAPAGLIFLOZIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1488569	dapagliflozin 10 MG Oral Tablet	PSN	72ad22ae-efe6-4cd6-a302-98aaee423d69	45
1488574	dapagliflozin 5 MG Oral Tablet	PSN	72ad22ae-efe6-4cd6-a302-98aaee423d69	45
1486977	farxiga 10 MG Oral Tablet	PSN	72ad22ae-efe6-4cd6-a302-98aaee423d69	45
1486981	farxiga 5 MG Oral Tablet	PSN	72ad22ae-efe6-4cd6-a302-98aaee423d69	45
1486977	dapagliflozin 10 MG Oral Tablet [Farxiga]	SBD	72ad22ae-efe6-4cd6-a302-98aaee423d69	45
1486981	dapagliflozin 5 MG Oral Tablet [Farxiga]	SBD	72ad22ae-efe6-4cd6-a302-98aaee423d69	45
1488569	dapagliflozin 10 MG Oral Tablet	SCD	72ad22ae-efe6-4cd6-a302-98aaee423d69	45
1488574	dapagliflozin 5 MG Oral Tablet	SCD	72ad22ae-efe6-4cd6-a302-98aaee423d69	45
1488569	dapagliflozin 10 MG Oral Tablet	SY	72ad22ae-efe6-4cd6-a302-98aaee423d69	45
1488574	dapagliflozin 5 MG Oral Tablet	SY	72ad22ae-efe6-4cd6-a302-98aaee423d69	45
1486977	Farxiga 10 MG Oral Tablet	SY	72ad22ae-efe6-4cd6-a302-98aaee423d69	45
1486981	Farxiga 5 MG Oral Tablet	SY	72ad22ae-efe6-4cd6-a302-98aaee423d69	45
1488569	dapagliflozin 10 MG Oral Tablet	PSN	40cc4f5d-bcf6-4016-9d1e-838bbc4bdddc	20
1488574	dapagliflozin 5 MG Oral Tablet	PSN	40cc4f5d-bcf6-4016-9d1e-838bbc4bdddc	20
1486977	farxiga 10 MG Oral Tablet	PSN	40cc4f5d-bcf6-4016-9d1e-838bbc4bdddc	20
1486981	farxiga 5 MG Oral Tablet	PSN	40cc4f5d-bcf6-4016-9d1e-838bbc4bdddc	20
1486977	dapagliflozin 10 MG Oral Tablet [Farxiga]	SBD	40cc4f5d-bcf6-4016-9d1e-838bbc4bdddc	20
1486981	dapagliflozin 5 MG Oral Tablet [Farxiga]	SBD	40cc4f5d-bcf6-4016-9d1e-838bbc4bdddc	20
1488569	dapagliflozin 10 MG Oral Tablet	SCD	40cc4f5d-bcf6-4016-9d1e-838bbc4bdddc	20
1488574	dapagliflozin 5 MG Oral Tablet	SCD	40cc4f5d-bcf6-4016-9d1e-838bbc4bdddc	20
1488569	dapagliflozin 10 MG Oral Tablet	SY	40cc4f5d-bcf6-4016-9d1e-838bbc4bdddc	20
1488574	dapagliflozin 5 MG Oral Tablet	SY	40cc4f5d-bcf6-4016-9d1e-838bbc4bdddc	20
1486977	Farxiga 10 MG Oral Tablet	SY	40cc4f5d-bcf6-4016-9d1e-838bbc4bdddc	20
1486981	Farxiga 5 MG Oral Tablet	SY	40cc4f5d-bcf6-4016-9d1e-838bbc4bdddc	20
1488569	dapagliflozin 10 MG Oral Tablet	PSN	01f90c94-71cb-4a1f-81ff-8004b850529b	15
1488574	dapagliflozin 5 MG Oral Tablet	PSN	01f90c94-71cb-4a1f-81ff-8004b850529b	15
1486977	farxiga 10 MG Oral Tablet	PSN	01f90c94-71cb-4a1f-81ff-8004b850529b	15
1486981	farxiga 5 MG Oral Tablet	PSN	01f90c94-71cb-4a1f-81ff-8004b850529b	15
1486977	dapagliflozin 10 MG Oral Tablet [Farxiga]	SBD	01f90c94-71cb-4a1f-81ff-8004b850529b	15
1486981	dapagliflozin 5 MG Oral Tablet [Farxiga]	SBD	01f90c94-71cb-4a1f-81ff-8004b850529b	15
1488569	dapagliflozin 10 MG Oral Tablet	SCD	01f90c94-71cb-4a1f-81ff-8004b850529b	15
1488574	dapagliflozin 5 MG Oral Tablet	SCD	01f90c94-71cb-4a1f-81ff-8004b850529b	15
1488569	dapagliflozin 10 MG Oral Tablet	SY	01f90c94-71cb-4a1f-81ff-8004b850529b	15
1488574	dapagliflozin 5 MG Oral Tablet	SY	01f90c94-71cb-4a1f-81ff-8004b850529b	15
1486977	Farxiga 10 MG Oral Tablet	SY	01f90c94-71cb-4a1f-81ff-8004b850529b	15
1486981	Farxiga 5 MG Oral Tablet	SY	01f90c94-71cb-4a1f-81ff-8004b850529b	15
1488574	dapagliflozin 5 MG Oral Tablet	PSN	ef9e9c8c-5460-4193-952a-0c249dd071bd	1
1486981	farxiga 5 MG Oral Tablet	PSN	ef9e9c8c-5460-4193-952a-0c249dd071bd	1
1486981	dapagliflozin 5 MG Oral Tablet [Farxiga]	SBD	ef9e9c8c-5460-4193-952a-0c249dd071bd	1
1488574	dapagliflozin 5 MG Oral Tablet	SCD	ef9e9c8c-5460-4193-952a-0c249dd071bd	1
1488574	dapagliflozin 5 MG Oral Tablet	SY	ef9e9c8c-5460-4193-952a-0c249dd071bd	1
1486981	Farxiga 5 MG Oral Tablet	SY	ef9e9c8c-5460-4193-952a-0c249dd071bd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0310-6205-30	00310620530	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6205-30)		2015-02-02	0000-00-00	No	No	Current
0310-6205-90	00310620590	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6205-90)		2024-03-18		No	No	Current
0310-6205-95	00310620595	1 BLISTER PACK in 1 CARTON (0310-6205-95) / 7 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2015-02-02	2027-12-31	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FARXIGA	REMEDYREPACK INC.	2026-09-18	HUMAN PRESCRIPTION DRUG LABEL	3
FARXIGA	A-S Medication Solutions	2026-07-10	HUMAN PRESCRIPTION DRUG LABEL	22
FARXIGA	AstraZeneca Pharmaceuticals LP	2026-06-03	HUMAN PRESCRIPTION DRUG LABEL	49
FARXIGA	Cardinal Health 107, LLC	2024-08-29	HUMAN PRESCRIPTION DRUG LABEL	20