Trikafta

Product NDC: 51167-445
11-digit product format: 511670445
Labeler code: 51167
Product ID: 51167-445_d16848f4-2958-44c0-b688-8a9b25d9032f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Elexacaftor, Tezacaftor, and Ivacaftor
Dosage form: KIT
Labeler: Vertex Pharmaceuticals Incorporated
Application: NDA217660
Marketing category: NDA
Marketing start: 2023-04-26
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
N217660-001	TRIKAFTA (COPACKAGED)	ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR	80MG, 60MG, 40MG;59.5MG	GRANULE / ORAL		RLD	2023-04-26
N217660-002	TRIKAFTA (COPACKAGED)	ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR	100MG, 75MG, 50MG;75MG	GRANULE / ORAL		RLD, RS	2023-04-26

Orange Book patents#

Current patent rows page 1 of 2 · 148 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217660-001	8354427	2026-07-06	U-3593		2023-05-24
N217660-001	8410274	2026-12-28		Drug product	2023-05-24
N217660-001	8754224	2026-12-28		Drug substance, Drug product	2023-05-24
N217660-001	9670163	2026-12-28	U-3591	Drug product	2023-05-24
N217660-001	9670163	2026-12-28	U-4068	Drug product	2023-05-24
N217660-001	9670163	2026-12-28	U-4478	Drug product	2023-05-24
N217660-001	9931334	2026-12-28	U-3591	Drug product	2023-05-24
N217660-001	9931334	2026-12-28	U-4068	Drug product	2023-05-24
N217660-001	9931334	2026-12-28	U-4478	Drug product	2023-05-24
N217660-001	10022352	2027-04-09	U-3596	Drug product	2023-05-24
N217660-001	10239867	2027-04-09	U-3590	Drug substance, Drug product	2023-05-24
N217660-001	10239867	2027-04-09	U-4053	Drug substance, Drug product	2023-05-24
N217660-001	10239867	2027-04-09	U-4476	Drug substance, Drug product	2023-05-24
N217660-001	11639347	2027-04-09	U-3583	Drug substance, Drug product	2023-05-24
N217660-001	11639347	2027-04-09	U-4053	Drug substance, Drug product	2023-05-24
N217660-001	11639347	2027-04-09	U-4476	Drug substance, Drug product	2023-05-24
N217660-001	9974781	2027-04-09	U-3589	Drug product	2023-05-24
N217660-001	9974781	2027-04-09	U-4066	Drug product	2023-05-24
N217660-001	9974781	2027-04-09	U-4476	Drug product	2023-05-24
N217660-001	7645789	2027-05-01		Drug substance, Drug product	2023-05-24
N217660-001	8598181	2027-05-01	U-3589		2023-05-24
N217660-001	8598181	2027-05-01	U-4066		2023-05-24
N217660-001	8598181	2027-05-01	U-4476		2023-05-24
N217660-001	8623905	2027-05-01		Drug substance, Drug product	2023-05-24
N217660-001	7495103	2027-05-20		Drug substance, Drug product	2023-05-24
N217660-001	7776905	2027-06-03		Drug substance, Drug product	2023-05-24
N217660-001	8324242	2027-08-05	U-3589		2023-05-24
N217660-001	8324242	2027-08-05	U-4066		2023-05-24
N217660-001	8324242	2027-08-05	U-4476		2023-05-24
N217660-001	8415387	2027-11-12	U-3589		2023-05-24
N217660-001	8415387	2027-11-12	U-4066		2023-05-24
N217660-001	8415387	2027-11-12	U-4476		2023-05-24
N217660-001	10646481	2029-08-13		Drug product	2023-05-24
N217660-001	11564916	2029-08-13	U-3585		2023-05-24
N217660-001	11564916	2029-08-13	U-4055		2023-05-24
N217660-001	11564916	2029-08-13	U-4485		2023-05-24
N217660-001	12458635	2029-08-13	U-4333	Drug product	2025-11-21
N217660-001	12458635	2029-08-13	U-4493	Drug product	2025-11-21
N217660-001	10081621	2031-03-25	U-3600	Drug product	2023-05-24
N217660-001	10081621	2031-03-25	U-4065	Drug product	2023-05-24
N217660-001	10081621	2031-03-25	U-4481	Drug product	2023-05-24
N217660-001	11578062	2031-03-25	U-3584	Drug product	2023-05-24
N217660-001	11578062	2031-03-25	U-4054	Drug product	2023-05-24
N217660-001	11578062	2031-03-25	U-4488	Drug product	2023-05-24
N217660-001	RE50453	2031-07-10		Drug substance, Drug product	2025-07-11
N217660-001	10272046	2033-02-27	U-3599	Drug product	2023-05-24
N217660-001	10272046	2033-02-27	U-4062	Drug product	2023-05-24
N217660-001	10272046	2033-02-27	U-4482	Drug product	2023-05-24
N217660-001	11147770	2033-02-27	U-3598	Drug product	2023-05-24
N217660-001	11147770	2033-02-27	U-4060	Drug product	2023-05-24
N217660-001	11147770	2033-02-27	U-4483	Drug product	2023-05-24
N217660-001	11752106	2033-02-27	U-3696	Drug product	2023-10-11
N217660-001	11752106	2033-02-27	U-4052	Drug product	2023-10-11
N217660-001	11752106	2033-02-27	U-4489	Drug product	2023-10-11
N217660-001	12214083	2033-02-27	U-4141	Drug product	2025-03-03
N217660-001	12214083	2033-02-27	U-4492	Drug product	2025-03-03
N217660-001	8883206	2033-02-27		Drug product	2023-05-24
N217660-001	10758534	2035-10-06	U-3589	Drug substance, Drug product	2023-05-24
N217660-001	10758534	2035-10-06	U-4066	Drug substance, Drug product	2023-05-24
N217660-001	10758534	2035-10-06	U-4476	Drug substance, Drug product	2023-05-24
N217660-001	11426407	2035-10-06	U-3595	Drug substance, Drug product	2023-05-24
N217660-001	11426407	2035-10-06	U-4058	Drug substance, Drug product	2023-05-24
N217660-001	11426407	2035-10-06	U-4476	Drug substance, Drug product	2023-05-24
N217660-001	10793547	2037-12-08	U-3588	Drug substance, Drug product	2023-05-24
N217660-001	10793547	2037-12-08	U-4066	Drug substance, Drug product	2023-05-24
N217660-001	10793547	2037-12-08	U-4476	Drug substance, Drug product	2023-05-24
N217660-001	11179367	2037-12-08	U-3597	Drug product	2023-05-24
N217660-001	11179367	2037-12-08	U-4059	Drug product	2023-05-24
N217660-001	11179367	2037-12-08	U-4484	Drug product	2023-05-24
N217660-001	11453655	2037-12-08		Drug substance, Drug product	2023-05-24
N217660-001	11517564	2037-12-08	U-3586	Drug product	2023-05-24
N217660-001	11517564	2037-12-08	U-4057	Drug product	2023-05-24
N217660-001	11517564	2037-12-08	U-4476	Drug product	2023-05-24
N217660-002	8354427	2026-07-06	U-3593		2023-05-24
N217660-002	8410274	2026-12-28		Drug product	2023-05-24
N217660-002	8754224	2026-12-28		Drug substance, Drug product	2023-05-24
N217660-002	9670163	2026-12-28	U-3591	Drug product	2023-05-24
N217660-002	9670163	2026-12-28	U-4068	Drug product	2023-05-24
N217660-002	9670163	2026-12-28	U-4478	Drug product	2023-05-24
N217660-002	9931334	2026-12-28	U-3591	Drug product	2023-05-24

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 9 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217660-001	NP	2026-04-26
N217660-001	M-313	2027-12-20
N217660-001	ODE-433	2030-04-26
N217660-001	ODE-512	2031-12-20
N217660-001	ODE-543	2033-03-27
N217660-002	NP	2026-04-26
N217660-002	ODE-433	2030-04-26
N217660-002	ODE-512	2031-12-20
N217660-002	ODE-543	2033-03-27

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 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N217660-001	TRIKAFTA (COPACKAGED)	80MG, 60MG, 40MG;59.5MG	GRANULE / ORAL	RLD	2023-04-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-002	TRIKAFTA (COPACKAGED)	100MG, 75MG, 50MG;75MG	GRANULE / ORAL	RLD, RS	2023-04-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217660-001	TRIKAFTA (COPACKAGED)	80MG, 60MG, 40MG;59.5MG	GRANULE / ORAL	RLD	2023-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217660-002	TRIKAFTA (COPACKAGED)	100MG, 75MG, 50MG;75MG	GRANULE / ORAL	RLD, RS	2023-04-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217660-001	TRIKAFTA (COPACKAGED)	80MG, 60MG, 40MG;59.5MG	GRANULES / ORAL	RLD	2023-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217660-002	TRIKAFTA (COPACKAGED)	100MG, 75MG, 50MG;75MG	GRANULES / ORAL	RLD, RS	2023-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217660-001	TRIKAFTA (COPACKAGED)	80MG, 60MG, 40MG;59.5MG	GRANULES / ORAL	RLD	2023-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217660-002	TRIKAFTA (COPACKAGED)	100MG, 75MG, 50MG;75MG	GRANULES / ORAL	RLD, RS	2023-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217660-001	TRIKAFTA (COPACKAGED)	80MG, 60MG, 40MG;59.5MG	GRANULES / ORAL	RLD	2023-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217660-002	TRIKAFTA (COPACKAGED)	100MG, 75MG, 50MG;75MG	GRANULES / ORAL	RLD, RS	2023-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217660-001	TRIKAFTA (COPACKAGED)	80MG, 60MG, 40MG;59.5MG	GRANULES / ORAL	RLD	2023-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217660-002	TRIKAFTA (COPACKAGED)	100MG, 75MG, 50MG;75MG	GRANULES / ORAL	RLD, RS	2023-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217660-001	TRIKAFTA (COPACKAGED)	80MG, 60MG, 40MG;59.5MG	GRANULES / ORAL	RLD	2023-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217660-002	TRIKAFTA (COPACKAGED)	100MG, 75MG, 50MG;75MG	GRANULES / ORAL	RLD, RS	2023-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217660-001	TRIKAFTA (COPACKAGED)	80MG, 60MG, 40MG;59.5MG	GRANULES / ORAL	RLD	2023-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217660-002	TRIKAFTA (COPACKAGED)	100MG, 75MG, 50MG;75MG	GRANULES / ORAL	RLD, RS	2023-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217660-001	TRIKAFTA (COPACKAGED)	80MG, 60MG, 40MG;59.5MG	GRANULES / ORAL	RLD	2023-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217660-002	TRIKAFTA (COPACKAGED)	100MG, 75MG, 50MG;75MG	GRANULES / ORAL	RLD, RS	2023-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217660-001	TRIKAFTA (COPACKAGED)	80MG, 60MG, 40MG;59.5MG	GRANULES / ORAL	RLD	2023-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217660-002	TRIKAFTA (COPACKAGED)	100MG, 75MG, 50MG;75MG	GRANULES / ORAL	RLD, RS	2023-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217660-001	TRIKAFTA (COPACKAGED)	80MG, 60MG, 40MG;59.5MG	GRANULES / ORAL	RLD	2023-04-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217660-002	TRIKAFTA (COPACKAGED)	100MG, 75MG, 50MG;75MG	GRANULES / ORAL	RLD, RS	2023-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217660-001	TRIKAFTA (COPACKAGED)	80MG, 60MG, 40MG;59.5MG	GRANULES / ORAL	RLD	2023-04-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217660-002	TRIKAFTA (COPACKAGED)	100MG, 75MG, 50MG;75MG	GRANULES / ORAL	RLD, RS	2023-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217660-001	TRIKAFTA (COPACKAGED)	80MG, 60MG, 40MG;59.5MG	GRANULES / ORAL	RLD	2023-04-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217660-002	TRIKAFTA (COPACKAGED)	100MG, 75MG, 50MG;75MG	GRANULES / ORAL	RLD, RS	2023-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217660-001	TRIKAFTA (COPACKAGED)	80MG, 60MG, 40MG;59.5MG	GRANULES / ORAL	RLD	2023-04-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217660-002	TRIKAFTA (COPACKAGED)	100MG, 75MG, 50MG;75MG	GRANULES / ORAL	RLD, RS	2023-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217660-001	TRIKAFTA (COPACKAGED)	80MG, 60MG, 40MG;59.5MG	GRANULES / ORAL	RLD	2023-04-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217660-002	TRIKAFTA (COPACKAGED)	100MG, 75MG, 50MG;75MG	GRANULES / ORAL	RLD, RS	2023-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217660-001	TRIKAFTA (COPACKAGED)	80MG, 60MG, 40MG;59.5MG	GRANULES / ORAL	RLD	2023-04-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N217660-002	TRIKAFTA (COPACKAGED)	100MG, 75MG, 50MG;75MG	GRANULES / ORAL	RLD, RS	2023-04-26	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217660-001	TRIKAFTA (COPACKAGED)	80MG, 60MG, 40MG;59.5MG	GRANULES / ORAL	RLD	2023-04-26	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217660-002	TRIKAFTA (COPACKAGED)	100MG, 75MG, 50MG;75MG	GRANULES / ORAL	RLD, RS	2023-04-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217660-001	TRIKAFTA (COPACKAGED)	80MG, 60MG, 40MG;59.5MG	GRANULES / ORAL	RLD	2023-04-26	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N217660-002	TRIKAFTA (COPACKAGED)	100MG, 75MG, 50MG;75MG	GRANULES / ORAL	RLD, RS	2023-04-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217660-001	TRIKAFTA (COPACKAGED)	80MG, 60MG, 40MG;59.5MG	GRANULES / ORAL	RLD	2023-04-26	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N217660-002	TRIKAFTA (COPACKAGED)	100MG, 75MG, 50MG;75MG	GRANULES / ORAL	RLD, RS	2023-04-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217660-001	TRIKAFTA (COPACKAGED)	80MG, 60MG, 40MG;59.5MG	GRANULES / ORAL	RLD	2023-04-26	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217660-002	TRIKAFTA (COPACKAGED)	100MG, 75MG, 50MG;75MG	GRANULES / ORAL	RLD, RS	2023-04-26	`a72a2bbeb626…`

Observed Orange Book patent history#

Patent history page 1 of 49 · 1,959 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	N217660-001	8354427	2026-07-06	U-3593		2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	8410274	2026-12-28		Drug product	2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	8754224	2026-12-28		Drug substance, Drug product	2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	9670163	2026-12-28	U-4068	Drug product	2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	9670163	2026-12-28	U-3591	Drug product	2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	9670163	2026-12-28	U-4478	Drug product	2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	9931334	2026-12-28	U-4068	Drug product	2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	9931334	2026-12-28	U-3591	Drug product	2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	9931334	2026-12-28	U-4478	Drug product	2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	10022352	2027-04-09	U-3596	Drug product	2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	10239867	2027-04-09	U-3590	Drug substance, Drug product	2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	10239867	2027-04-09	U-4053	Drug substance, Drug product	2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	10239867	2027-04-09	U-4476	Drug substance, Drug product	2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	11639347	2027-04-09	U-3583	Drug substance, Drug product	2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	11639347	2027-04-09	U-4053	Drug substance, Drug product	2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	11639347	2027-04-09	U-4476	Drug substance, Drug product	2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	9974781	2027-04-09	U-4066	Drug product	2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	9974781	2027-04-09	U-3589	Drug product	2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	9974781	2027-04-09	U-4476	Drug product	2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	7645789	2027-05-01		Drug substance, Drug product	2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	8598181	2027-05-01	U-4066		2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	8598181	2027-05-01	U-3589		2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	8598181	2027-05-01	U-4476		2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	8623905	2027-05-01		Drug substance, Drug product	2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	7495103	2027-05-20		Drug substance, Drug product	2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	7776905	2027-06-03		Drug substance, Drug product	2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	8324242	2027-08-05	U-4066		2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	8324242	2027-08-05	U-3589		2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	8324242	2027-08-05	U-4476		2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	8415387	2027-11-12	U-3589		2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	8415387	2027-11-12	U-4066		2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	8415387	2027-11-12	U-4476		2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	10646481	2029-08-13		Drug product	2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	11564916	2029-08-13	U-3585		2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	11564916	2029-08-13	U-4055		2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	11564916	2029-08-13	U-4485		2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	12458635	2029-08-13	U-4333	Drug product	2025-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	12458635	2029-08-13	U-4493	Drug product	2025-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	10081621	2031-03-25	U-4065	Drug product	2023-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	10081621	2031-03-25	U-3600	Drug product	2023-05-24	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 151 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	N217660-001	NP	2026-04-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	M-313	2027-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	ODE-433	2030-04-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	ODE-512	2031-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-001	ODE-543	2033-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-002	NP	2026-04-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-002	ODE-433	2030-04-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-002	ODE-512	2031-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217660-002	ODE-543	2033-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217660-001	NP	2026-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217660-001	M-313	2027-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217660-001	ODE-433	2030-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217660-001	ODE-512	2031-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217660-001	ODE-543	2033-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217660-002	NP	2026-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217660-002	ODE-433	2030-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217660-002	ODE-512	2031-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217660-002	ODE-543	2033-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217660-001	NP	2026-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217660-001	M-313	2027-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217660-001	ODE-433	2030-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217660-001	ODE-512	2031-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217660-002	NP	2026-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217660-002	ODE-433	2030-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217660-002	ODE-512	2031-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217660-001	NP	2026-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217660-001	M-313	2027-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217660-001	ODE-433	2030-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217660-001	ODE-512	2031-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217660-002	NP	2026-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217660-002	ODE-433	2030-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217660-002	ODE-512	2031-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217660-001	NP	2026-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217660-001	M-313	2027-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217660-001	ODE-433	2030-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217660-001	ODE-512	2031-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217660-002	NP	2026-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217660-002	ODE-433	2030-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217660-002	ODE-512	2031-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217660-001	NP	2026-04-26	`fd3edfee7708…`

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 16 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1243046	Internal RxNorm lookup
1606868	Internal RxNorm lookup
2174388	Internal RxNorm lookup
2257011	Internal RxNorm lookup
2257012	Internal RxNorm lookup
2257013	Internal RxNorm lookup
2557214	Internal RxNorm lookup
2557215	Internal RxNorm lookup
2557216	Internal RxNorm lookup
2635013	Internal RxNorm lookup
2635020	Internal RxNorm lookup
2635021	Internal RxNorm lookup
2635022	Internal RxNorm lookup
2635024	Internal RxNorm lookup
2635025	Internal RxNorm lookup
2635026	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
f354423a-85c2-41c3-a9db-0f3aee135d8d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
29f82424-66ff-4356-862a-3564547225ea	Product name	1	20250819
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
3345c65e-7c51-4ee3-a410-af7ec8592f92	Product name	2	20231010
31b21435-431d-4752-a7c5-89c6a41c6338	Product name	4	20230626
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
eaf14f5a-a483-45c2-b6bb-bda37f923e37	Product name	1	20180508
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
1c108d2a-865b-9f48-5b3a-b52233297e1d	Product name	2	20150417
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51167-445-01	Trikafta	1 in 1 PACKAGE	KIT	1		22
51167-445-01	Trikafta	4 in 1 CARTON	KIT	4		22
51167-545-07	Trikafta	1 in 1 PACKET	GRANULE	7	80 mg	22
51167-645-07	Trikafta	1 in 1 PACKET	GRANULE	7	59.5 mg	22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51167-445-01	EA - Each	51167-445	a481db85-c2bd-4a16-bd23-9dcae0f3165b	1	2023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51167-445	TRIKAFTA (ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR) KIT [VERTEX PHARMACEUTICALS INCORPORATED]	20	Current NDC, 4 package rows	20250215_f354423a-85c2-41c3-a9db-0f3aee135d8d.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trikafta	ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR	Vertex Pharmaceuticals Incorporated	f354423a-85c2-41c3-a9db-0f3aee135d8d	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 217660 application number: NDA217660 ndc (product): 51167-445

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2635026	{28 (elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Granules) / 28 (ivacaftor 75 MG Oral Granules) } Pack [Trikafta (100 MG / 50 MG / 75 MG; 75 MG) Granules]	BPCK	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2635022	{28 (elexacaftor 80 MG / ivacaftor 60 MG / tezacaftor 40 MG Oral Granules) / 28 (ivacaftor 59.5 MG Oral Granules) } Pack [Trikafta (80 MG / 40 MG / 60 MG; 59.5 MG) Granules]	BPCK	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2257013	{56 (elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Tablet) / 28 (ivacaftor 150 MG Oral Tablet) } Pack [Trikafta (100 MG / 50 MG / 75 MG; 150 MG)]	BPCK	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2557216	{56 (elexacaftor 50 MG / ivacaftor 37.5 MG / tezacaftor 25 MG Oral Tablet) / 28 (ivacaftor 75 MG Oral Tablet) } Pack [Trikafta (50 MG / 37.5 MG / 25 MG; 75 MG)]	BPCK	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2635025	{28 (elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Granules) / 28 (ivacaftor 75 MG Oral Granules) } Pack	GPCK	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2635021	{28 (elexacaftor 80 MG / ivacaftor 60 MG / tezacaftor 40 MG Oral Granules) / 28 (ivacaftor 59.5 MG Oral Granules) } Pack	GPCK	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2257012	{56 (elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Tablet) / 28 (ivacaftor 150 MG Oral Tablet) } Pack	GPCK	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2557215	{56 (elexacaftor 50 MG / ivacaftor 37.5 MG / tezacaftor 25 MG Oral Tablet) / 28 (ivacaftor 75 MG Oral Tablet) } Pack	GPCK	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2635024	elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Granules	PSN	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2635025	elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Granules (28) / ivacaftor 75 MG Oral Granules (28) Pack	PSN	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2257011	elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Tablet	PSN	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2257012	elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Tablet (56) and ivacaftor 150 MG Oral Tablet (28) Pack	PSN	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2557214	elexacaftor 50 MG / ivacaftor 37.5 MG / tezacaftor 25 MG Oral Tablet	PSN	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2557215	elexacaftor 50 MG / ivacaftor 37.5 MG / tezacaftor 25 MG Oral Tablet (56) and ivacaftor 75 MG Oral Tablet (28) Pack	PSN	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2635013	elexacaftor 80 MG / ivacaftor 60 MG / tezacaftor 40 MG Oral Granules	PSN	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2635021	elexacaftor 80 MG / ivacaftor 60 MG / tezacaftor 40 MG Oral Granules (28) / ivacaftor 59.5 MG Oral Granules (28) Pack	PSN	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
1243046	ivacaftor 150 MG Oral Tablet	PSN	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2635020	ivacaftor 59.5 MG Oral Granules	PSN	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
1606868	ivacaftor 75 MG Oral Granules	PSN	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2174388	ivacaftor 75 MG Oral Tablet	PSN	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2257013	trikafta 100 MG / 50 MG / 75 MG and 150 MG Tablet Pack	PSN	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2635026	trikafta 100 MG / 50 MG / 75 MG and 75 MG Oral Granules Pack	PSN	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2557216	trikafta 50 MG / 37.5 MG / 25 MG and 75 MG Pack	PSN	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2635022	trikafta 80 MG / 40 MG / 60 MG and 59.5 MG Oral Granules Pack	PSN	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2635024	elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Granules	SCD	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2257011	elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Tablet	SCD	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2557214	elexacaftor 50 MG / ivacaftor 37.5 MG / tezacaftor 25 MG Oral Tablet	SCD	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2635013	elexacaftor 80 MG / ivacaftor 60 MG / tezacaftor 40 MG Oral Granules	SCD	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
1243046	ivacaftor 150 MG Oral Tablet	SCD	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2635020	ivacaftor 59.5 MG Oral Granules	SCD	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
1606868	ivacaftor 75 MG Oral Granules	SCD	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2174388	ivacaftor 75 MG Oral Tablet	SCD	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2635025	elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Granules (28) / ivacaftor 75 MG Oral Granules (28) Pack	SY	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2257012	elexacaftor 100 MG / ivacaftor 75 MG / tezacaftor 50 MG Oral Tablet (56) and ivacaftor 150 MG Oral Tablet (28) Pack	SY	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2557215	elexacaftor 50 MG / ivacaftor 37.5 MG / tezacaftor 25 MG Oral Tablet (56) and ivacaftor 75 MG Oral Tablet (28) Pack	SY	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2635021	elexacaftor 80 MG / ivacaftor 60 MG / tezacaftor 40 MG Oral Granules (28) / ivacaftor 59.5 MG Oral Granules (28) Pack	SY	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2257013	trikafta 100 MG / 50 MG / 75 MG and 150 MG Tablet Pack	SY	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2635026	Trikafta 100 MG / 50 MG / 75 MG and 75 MG Oral Granules Pack	SY	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2557216	trikafta 50 MG / 37.5 MG / 25 MG and 75 MG Pack	SY	f354423a-85c2-41c3-a9db-0f3aee135d8d	22
2635022	Trikafta 80 MG / 40 MG / 60 MG and 59.5 MG Oral Granules Pack	SY	f354423a-85c2-41c3-a9db-0f3aee135d8d	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51167-445-01	51167044501	4 PACKAGE in 1 CARTON (51167-445-01) / 1 KIT in 1 PACKAGE * 1 GRANULE in 1 PACKET (51167-545-07) * 1 GRANULE in 1 PACKET (51167-645-07)	4 package	2023-04-26	No	No	Current
51167-545-07	51167054507	1 in 1 PACKET					Historical
51167-645-07	51167064507	1 in 1 PACKET					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trikafta	Vertex Pharmaceuticals Incorporated \| AndersonBrecon Inc. \| Shanghai SynTheAll Pharmaceutical, Co., Ltd. \| F.I.S. Fabbrica Italiana Sintetici S.P.A. \| Pharmaceutical Manufacturing Research Services, Inc. \| Almac Pharma Services LLC	2026-06-22	HUMAN PRESCRIPTION DRUG LABEL	23