DAPAGLIFLOZIN

Product NDC: 63629-3253
11-digit product format: 636293253
Labeler code: 63629
Product ID: 63629-3253_4ef8db0b-c28e-44ff-bf60-a9f8018c5861
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DAPAGLIFLOZIN
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: NDA202293
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2024-01-03
Substance: DAPAGLIFLOZIN PROPANEDIOL
Active strength: 10 mg/1
Pharmacologic classes: 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
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.

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
2026-08-01 22:54:32	2026-06	N202293-001	FARXIGA	5MG	TABLET / ORAL	AB	RLD	2014-01-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	FARXIGA	10MG	TABLET / ORAL	AB	RLD, RS	2014-01-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N202293-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N202293-001	6515117	2025-10-04	U-493	Drug substance, Drug product	2014-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	6515117	2025-10-04	U-2139	Drug substance, Drug product	2014-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	6515117*PED	2026-04-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8329648	2026-08-18	U-2213		2017-11-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8329648	2026-08-18	U-2139		2017-11-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8329648	2026-08-18	U-2212		2017-11-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8906851	2026-08-18	U-2139		2017-11-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8329648*PED	2027-02-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8906851*PED	2027-02-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8501698	2027-06-20	U-493	Drug product	2014-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8501698*PED	2027-12-20		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8221786	2028-03-21		Drug product	2014-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8361972	2028-03-21	U-2139		2014-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8361972	2028-03-21	U-493		2014-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8716251	2028-03-21		Drug product	2014-06-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	7851502	2028-08-19		Drug product	2014-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8221786*PED	2028-09-21		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8361972*PED	2028-09-21		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8716251*PED	2028-09-21		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	7851502*PED	2029-02-19		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	7919598	2029-12-16		Drug substance	2014-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8721615	2030-01-18		Drug product, Delist requested	2017-11-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8685934	2030-05-26	U-1522		2014-06-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	7919598*PED	2030-06-16		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8721615*PED	2030-07-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	8685934*PED	2030-11-26		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	6515117	2025-10-04	U-2139	Drug substance, Drug product	2014-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	6515117	2025-10-04	U-493	Drug substance, Drug product	2014-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	6515117*PED	2026-04-04		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	8329648	2026-08-18	U-2139		2017-11-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	8329648	2026-08-18	U-2212		2017-11-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	8329648	2026-08-18	U-2213		2017-11-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	8906851	2026-08-18	U-2139		2017-11-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	8329648*PED	2027-02-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	8906851*PED	2027-02-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	8501698	2027-06-20	U-493	Drug product	2014-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	8501698*PED	2027-12-20		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	8221786	2028-03-21		Drug product	2014-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	8361972	2028-03-21	U-2139		2014-02-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	8361972	2028-03-21	U-493		2014-02-05	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-01 22:54:32	2026-06	N202293-001	M-298	2026-05-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	PED	2026-11-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	NPP	2027-06-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-001	PED	2027-12-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	M-298	2026-05-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	PED	2026-11-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	NPP	2027-06-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N202293-002	PED	2027-12-12	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 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
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
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	REMEDYREPACK INC.	ef9e9c8c-5460-4193-952a-0c249dd071bd	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202293 application number: NDA202293
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 ndc (product): 63629-3253
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

Additional Listing Data#

Finished product: Yes
Brand name base: DAPAGLIFLOZIN
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DAPAGLIFLOZIN PROPANEDIOL	10 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1488569	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
979205ee-b0b8-4483-ae61-f283f750bb7f	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
63629-3253-1	DAPAGLIFLOZIN	30 in 1 BOTTLE	TABLET, FILM COATED	30		101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-3253-1	EA - Each	63629-3253	5c0402f4-8915-4804-9c4b-c44510c4c3a5	1	2025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-3253	DAPAGLIFLOZIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	101	Current NDC, 1 package rows	20240820_979205ee-b0b8-4483-ae61-f283f750bb7f.zip

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	979205ee-b0b8-4483-ae61-f283f750bb7f	101
1488569	dapagliflozin 10 MG Oral Tablet	SCD	979205ee-b0b8-4483-ae61-f283f750bb7f	101
1488569	dapagliflozin 10 MG Oral Tablet	SY	979205ee-b0b8-4483-ae61-f283f750bb7f	101

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
63629-3253-1	63629325301	30 TABLET, FILM COATED in 1 BOTTLE (63629-3253-1)	2024-01-24	No	No	Current