FARXIGA

Product NDC: 70518-4614
11-digit product format: 705184614
Labeler code: 70518
Product ID: 70518-4614_503414ef-02c7-ce5b-e063-6294a90a5f09
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DAPAGLIFLOZIN
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: NDA202293
Marketing category: NDA
Marketing start: 2026-04-23
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 42.

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 · 84 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	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…`
2022-03-09 01:35 UTC	2022-03	N202293-001	FARXIGA	5MG	TABLET / ORAL		RLD	2014-01-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N202293-002	FARXIGA	10MG	TABLET / ORAL		RLD, RS	2014-01-08	`bb7c543d1eb4…`

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	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 55 · 2,162 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	N202293-001	6515117	2025-10-04	U-493	Drug substance, Drug product	2014-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	6515117	2025-10-04	U-2139	Drug substance, Drug product	2014-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	6515117*PED	2026-04-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8329648	2026-08-18	U-2213		2017-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8329648	2026-08-18	U-2139		2017-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8329648	2026-08-18	U-2212		2017-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8906851	2026-08-18	U-2139		2017-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8329648*PED	2027-02-18		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8906851*PED	2027-02-18		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8501698	2027-06-20	U-493	Drug product	2014-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8501698*PED	2027-12-20		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8221786	2028-03-21		Drug product	2014-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8361972	2028-03-21	U-2139		2014-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8361972	2028-03-21	U-493		2014-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8716251	2028-03-21		Drug product	2014-06-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	7851502	2028-08-19		Drug product	2014-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8221786*PED	2028-09-21		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8361972*PED	2028-09-21		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8716251*PED	2028-09-21		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	7851502*PED	2029-02-19		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	7919598	2029-12-16		Drug substance	2014-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8721615	2030-01-18		Drug product, Delist requested	2017-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8685934	2030-05-26	U-1522		2014-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	7919598*PED	2030-06-16		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8721615*PED	2030-07-18		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-001	8685934*PED	2030-11-26		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	6515117	2025-10-04	U-2139	Drug substance, Drug product	2014-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	6515117	2025-10-04	U-493	Drug substance, Drug product	2014-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	6515117*PED	2026-04-04		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	8329648	2026-08-18	U-2139		2017-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	8329648	2026-08-18	U-2212		2017-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	8329648	2026-08-18	U-2213		2017-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	8906851	2026-08-18	U-2139		2017-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	8329648*PED	2027-02-18		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	8906851*PED	2027-02-18		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	8501698	2027-06-20	U-493	Drug product	2014-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	8501698*PED	2027-12-20		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	8221786	2028-03-21		Drug product	2014-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	8361972	2028-03-21	U-2139		2014-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202293-002	8361972	2028-03-21	U-493		2014-02-05	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 8 · 306 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	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…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202293-001	M-298	2026-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202293-001	PED	2026-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202293-001	NPP	2027-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202293-001	PED	2027-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202293-002	M-298	2026-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202293-002	PED	2026-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202293-002	NPP	2027-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202293-002	PED	2027-12-12	`fd3edfee7708…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1486981	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
ef9e9c8c-5460-4193-952a-0c249dd071bd	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	Strength	SPL version
70518-4614-0	FARXIGA	50 in 1 BOX	TABLET, FILM COATED	50		1
70518-4614-1	FARXIGA	1 in 1 POUCH	TABLET, FILM COATED	1		1

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 · 7 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
FARXIGA	DAPAGLIFLOZIN	REMEDYREPACK INC.	ef9e9c8c-5460-4193-952a-0c249dd071bd	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202293 application number: NDA202293 ndc (product): 70518-4614
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
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	Sample	Exclude flag	Status
70518-4614-0	70518461400	50 POUCH in 1 BOX (70518-4614-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4614-1)	50 pouch	2026-04-23	No	No	Current
70518-4614-1	70518461401	1 in 1 POUCH					Historical