KYGEVVI

Product NDC: 50474-350
11-digit product format: 504740350
Labeler code: 50474
Product ID: 50474-350_5df97da6-79b6-deb8-e063-6294a90a027a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxecitine and doxribtimine
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: UCB, Inc.
Application: NDA219792
Marketing category: NDA
Marketing start: 2026-03-01
Substance: DOXECITINE; DOXRIBTIMINE
Active strength: 2; 2 g/1; g/1
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 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N219792-001	KYGEVVI	DOXECITINE; DOXRIBTIMINE	2GM/PACKET;2GM/PACKET	FOR SOLUTION / ORAL		RLD, RS	2025-11-03

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219792-001	10471087	2036-08-07	U-4358		2025-12-16
N219792-001	11649259	2040-08-19	U-4358	Drug product	2025-12-16

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219792-001	NCE	2030-11-03

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	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N219792-001	KYGEVVI	2GM/PACKET;2GM/PACKET	FOR SOLUTION / ORAL	RLD, RS	2025-11-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N219792-001	KYGEVVI	2GM/PACKET;2GM/PACKET	FOR SOLUTION / ORAL	RLD, RS	2025-11-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219792-001	KYGEVVI	2GM/PACKET;2GM/PACKET	FOR SOLUTION / ORAL	RLD, RS	2025-11-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219792-001	KYGEVVI	2GM/PACKET;2GM/PACKET	FOR SOLUTION / ORAL	RLD, RS	2025-11-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219792-001	KYGEVVI	2GM/PACKET;2GM/PACKET	FOR SOLUTION / ORAL	RLD, RS	2025-11-03	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219792-001	KYGEVVI	2GM/PACKET;2GM/PACKET	FOR SOLUTION / ORAL	RLD, RS	2025-11-03	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N219792-001	10471087	2036-08-07	U-4358		2025-12-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219792-001	11649259	2040-08-19	U-4358	Drug product	2025-12-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N219792-001	10471087	2036-08-07	U-4358		2025-12-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219792-001	11649259	2040-08-19	U-4358	Drug product	2025-12-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219792-001	10471087	2036-08-07	U-4358		2025-12-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219792-001	11649259	2040-08-19	U-4358	Drug product	2025-12-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219792-001	10471087	2036-08-07	U-4358		2025-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219792-001	11649259	2040-08-19	U-4358	Drug product	2025-12-16	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219792-001	10471087	2036-08-07	U-4358		2025-12-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219792-001	11649259	2040-08-19	U-4358	Drug product	2025-12-16	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N219792-001	NCE	2030-11-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N219792-001	NCE	2030-11-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219792-001	NCE	2030-11-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219792-001	NCE	2030-11-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219792-001	NCE	2030-11-03	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219792-001	NCE	2030-11-03	`a50c72e98297…`

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: KYGEVVI
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXECITINE	2 g/1
DOXRIBTIMINE	2 g/1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50474-350-01	KYGEVVI	1 in 1 PACKET	POWDER, FOR SOLUTION	1		3
50474-350-30	KYGEVVI	30 in 1 CARTON	POWDER, FOR SOLUTION	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50474-350-01	EA - Each	50474-350	8ff39ff9-fbd6-497f-89bc-fafc4aba21f4	1	2026-04-20
50474-350-30	EA - Each	50474-350	86021315-33c0-483d-8be2-585837544518	1	2025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2737535	doxecitine 2 GM / doxribtimine 2 GM Powder for Oral Solution	PSN	7d5ce670-9314-4fd7-8b0a-1447910dcf9e	3
2737541	kygevvi 2 GM / 2 GM Powder for Oral Solution	PSN	7d5ce670-9314-4fd7-8b0a-1447910dcf9e	3
2737541	doxecitine 2000 MG / doxribtimine 2000 MG Powder for Oral Solution [Kygevvi]	SBD	7d5ce670-9314-4fd7-8b0a-1447910dcf9e	3
2737535	doxecitine 2000 MG / doxribtimine 2000 MG Powder for Oral Solution	SCD	7d5ce670-9314-4fd7-8b0a-1447910dcf9e	3
2737535	doxecitine 2 GM / doxribtimine 2 GM Powder for Oral Solution	SY	7d5ce670-9314-4fd7-8b0a-1447910dcf9e	3
2737541	Kygevvi (doxecitine 2 GM / doxribtimine 2 GM) Powder for Oral Solution	SY	7d5ce670-9314-4fd7-8b0a-1447910dcf9e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50474-350-01	50474035001	1 in 1 PACKET					Historical
50474-350-30	50474035030	30 PACKET in 1 CARTON (50474-350-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (50474-350-01)	30 packet	2026-03-01	No	No	Current