SYMDEKO

Product NDC: 51167-661
11-digit product format: 511670661
Labeler code: 51167
Product ID: 51167-661_6ec7a22b-ccd3-408e-9564-bf8b8278da39
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tezacaftor and Ivacaftor
Dosage form: KIT
Labeler: Vertex Pharmaceuticals Incorporated
Application: NDA210491
Marketing category: NDA
Marketing start: 2018-02-12
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
N210491-001	SYMDEKO (COPACKAGED)	IVACAFTOR; IVACAFTOR, TEZACAFTOR	150MG;150MG, 100MG	TABLET / ORAL		RLD, RS	2018-02-12
N210491-002	SYMDEKO (COPACKAGED)	IVACAFTOR; IVACAFTOR, TEZACAFTOR	75MG;75MG, 50MG	TABLET / ORAL		RLD	2019-06-21

Orange Book patents#

Current patent rows page 1 of 1 · 65 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210491-001	8354427	2026-07-06	U-3021		2021-01-14
N210491-001	8410274	2026-12-28		Drug product	2018-03-09
N210491-001	8754224	2026-12-28		Drug substance, Drug product	2018-03-09
N210491-001	9670163	2026-12-28	U-2246	Drug product	2018-03-09
N210491-001	9931334	2026-12-28	U-2275	Drug product	2018-05-01
N210491-001	9931334	2026-12-28	U-2575	Drug product	2018-05-01
N210491-001	10022352	2027-04-09	U-2343	Drug product	2018-08-08
N210491-001	10022352	2027-04-09	U-2573	Drug product	2018-08-08
N210491-001	10239867	2027-04-09	U-2512	Drug substance, Drug product	2019-04-19
N210491-001	10239867	2027-04-09	U-2569	Drug substance, Drug product	2019-04-19
N210491-001	11639347	2027-04-09	U-2569	Drug substance, Drug product	2023-05-22
N210491-001	9974781	2027-04-09	U-2318	Drug product	2018-06-20
N210491-001	9974781	2027-04-09	U-2574	Drug product	2018-06-20
N210491-001	7645789	2027-05-01		Drug substance, Drug product	2018-03-09
N210491-001	8598181	2027-05-01	U-2246		2018-03-09
N210491-001	8623905	2027-05-01		Drug substance, Drug product	2018-03-09
N210491-001	7495103	2027-05-20		Drug substance, Drug product	2018-03-09
N210491-001	7776905	2027-06-03		Drug substance, Drug product	2018-03-09
N210491-001	8324242	2027-08-05	U-2246		2018-03-09
N210491-001	8415387	2027-11-12	U-2246		2018-03-09
N210491-001	10646481	2029-08-13		Drug product	2020-06-08
N210491-001	11564916	2029-08-13	U-3527		2023-02-28
N210491-001	12458635	2029-08-13	U-4336	Drug product	2025-11-26
N210491-001	10081621	2031-03-25	U-3024	Drug product	2018-10-25
N210491-001	10081621	2031-03-25	U-3025	Drug product	2018-10-25
N210491-001	11578062	2031-03-25	U-3545	Drug product	2023-03-16
N210491-001	RE50453	2031-07-10		Drug substance, Drug product	2025-07-09
N210491-001	10058546	2033-07-15	U-3022		2018-09-21
N210491-001	10058546	2033-07-15	U-3023		2018-09-21
N210491-001	9012496	2033-07-15	U-2248		2018-03-09
N210491-001	10206877	2035-04-14	U-3026	Drug product	2019-03-20
N210491-001	10206877	2035-04-14	U-3027	Drug product	2019-03-20
N210491-001	11951212	2035-04-14	U-3894	Drug product	2024-05-02
N210491-002	8354427	2026-07-06	U-3021		2021-01-14
N210491-002	8410274	2026-12-28		Drug product	2019-07-17
N210491-002	8754224	2026-12-28		Drug substance, Drug product	2019-07-17
N210491-002	9670163	2026-12-28	U-2246	Drug product	2019-07-17
N210491-002	9931334	2026-12-28	U-2275	Drug product	2019-07-17
N210491-002	9931334	2026-12-28	U-2575	Drug product	2019-07-17
N210491-002	10022352	2027-04-09	U-2343	Drug product	2019-07-17
N210491-002	10022352	2027-04-09	U-2573	Drug product	2019-07-17
N210491-002	10239867	2027-04-09	U-2512	Drug substance, Drug product	2019-07-17
N210491-002	10239867	2027-04-09	U-2569	Drug substance, Drug product	2019-07-17
N210491-002	11639347	2027-04-09	U-2569	Drug substance, Drug product	2023-05-22
N210491-002	9974781	2027-04-09	U-2318	Drug product	2019-07-17
N210491-002	9974781	2027-04-09	U-2574	Drug product	2019-07-17
N210491-002	7645789	2027-05-01		Drug substance, Drug product	2019-07-17
N210491-002	8598181	2027-05-01	U-2246		2019-07-17
N210491-002	8623905	2027-05-01		Drug substance, Drug product	2019-07-17
N210491-002	7495103	2027-05-20		Drug substance, Drug product	2019-07-17
N210491-002	7776905	2027-06-03		Drug substance, Drug product	2019-07-17
N210491-002	8324242	2027-08-05	U-2246		2019-07-17
N210491-002	8415387	2027-11-12	U-2246		2019-07-17
N210491-002	10646481	2029-08-13		Drug product	2020-06-08
N210491-002	11564916	2029-08-13	U-3527		2023-02-28
N210491-002	12458635	2029-08-13	U-4336	Drug product	2025-11-26
N210491-002	10081621	2031-03-25	U-3024	Drug product	2019-07-17
N210491-002	10081621	2031-03-25	U-3025	Drug product	2019-07-17
N210491-002	11578062	2031-03-25	U-3545	Drug product	2023-03-16
N210491-002	RE50453	2031-07-10		Drug substance, Drug product	2025-07-09
N210491-002	10058546	2033-07-15	U-3022		2019-07-17
N210491-002	10058546	2033-07-15	U-3023		2019-07-17
N210491-002	9012496	2033-07-15	U-2248		2019-07-17
N210491-002	10206877	2035-04-14	U-3026	Drug product	2019-07-17
N210491-002	10206877	2035-04-14	U-3027	Drug product	2019-07-17

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N210491-001	ODE-247	2026-06-21
N210491-001	ODE-335	2027-12-21
N210491-002	ODE-247	2026-06-21
N210491-002	ODE-335	2027-12-21

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 · 83 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210491-001	SYMDEKO (COPACKAGED)	150MG,N/A;150MG, 100MG	TABLET, TABLET / ORAL	RLD, RS	2018-02-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210491-002	SYMDEKO (COPACKAGED)	75MG,N/A;75MG, 50MG	TABLET, TABLET / ORAL	RLD, RS	2019-06-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210491-001	SYMDEKO (COPACKAGED)	150MG;150MG, 100MG	TABLET / ORAL	RLD, RS	2018-02-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210491-002	SYMDEKO (COPACKAGED)	75MG;75MG, 50MG	TABLET / ORAL	RLD	2019-06-21	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 70 · 2,781 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	N210491-001	8354427	2026-07-06	U-3021		2021-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	8410274	2026-12-28		Drug product	2018-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	8754224	2026-12-28		Drug substance, Drug product	2018-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	9670163	2026-12-28	U-2246	Drug product	2018-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	9931334	2026-12-28	U-2575	Drug product	2018-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	9931334	2026-12-28	U-2275	Drug product	2018-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	10022352	2027-04-09	U-2573	Drug product	2018-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	10022352	2027-04-09	U-2343	Drug product	2018-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	10239867	2027-04-09	U-2569	Drug substance, Drug product	2019-04-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	10239867	2027-04-09	U-2512	Drug substance, Drug product	2019-04-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	11639347	2027-04-09	U-2569	Drug substance, Drug product	2023-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	9974781	2027-04-09	U-2318	Drug product	2018-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	9974781	2027-04-09	U-2574	Drug product	2018-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	7645789	2027-05-01		Drug substance, Drug product	2018-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	8598181	2027-05-01	U-2246		2018-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	8623905	2027-05-01		Drug substance, Drug product	2018-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	7495103	2027-05-20		Drug substance, Drug product	2018-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	7776905	2027-06-03		Drug substance, Drug product	2018-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	8324242	2027-08-05	U-2246		2018-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	8415387	2027-11-12	U-2246		2018-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	10646481	2029-08-13		Drug product	2020-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	11564916	2029-08-13	U-3527		2023-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	12458635	2029-08-13	U-4336	Drug product	2025-11-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	10081621	2031-03-25	U-3024	Drug product	2018-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	10081621	2031-03-25	U-3025	Drug product	2018-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	11578062	2031-03-25	U-3545	Drug product	2023-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	RE50453	2031-07-10		Drug substance, Drug product	2025-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	10058546	2033-07-15	U-3023		2018-09-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	10058546	2033-07-15	U-3022		2018-09-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	9012496	2033-07-15	U-2248		2018-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	10206877	2035-04-14	U-3027	Drug product	2019-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	10206877	2035-04-14	U-3026	Drug product	2019-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	11951212	2035-04-14	U-3894	Drug product	2024-05-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-002	8354427	2026-07-06	U-3021		2021-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-002	8410274	2026-12-28		Drug product	2019-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-002	8754224	2026-12-28		Drug substance, Drug product	2019-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-002	9670163	2026-12-28	U-2246	Drug product	2019-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-002	9931334	2026-12-28	U-2575	Drug product	2019-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-002	9931334	2026-12-28	U-2275	Drug product	2019-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-002	10022352	2027-04-09	U-2343	Drug product	2019-07-17	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 8 · 310 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	N210491-001	ODE-247	2026-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-001	ODE-335	2027-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-002	ODE-247	2026-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210491-002	ODE-335	2027-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210491-001	ODE-247	2026-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210491-001	ODE-335	2027-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210491-002	ODE-247	2026-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210491-002	ODE-335	2027-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210491-001	ODE-173	2025-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210491-001	ODE-247	2026-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210491-001	ODE-335	2027-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210491-002	ODE-173	2025-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210491-002	ODE-247	2026-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210491-002	ODE-335	2027-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210491-001	ODE-173	2025-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210491-001	ODE-247	2026-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210491-001	ODE-335	2027-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210491-002	ODE-173	2025-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210491-002	ODE-247	2026-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210491-002	ODE-335	2027-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210491-001	ODE-173	2025-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210491-001	ODE-247	2026-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210491-001	ODE-335	2027-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210491-002	ODE-173	2025-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210491-002	ODE-247	2026-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210491-002	ODE-335	2027-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210491-001	ODE-173	2025-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210491-001	ODE-247	2026-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210491-001	ODE-335	2027-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210491-002	ODE-173	2025-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210491-002	ODE-247	2026-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210491-002	ODE-335	2027-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210491-001	ODE-173	2025-02-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210491-001	ODE-247	2026-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210491-001	ODE-335	2027-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210491-002	ODE-173	2025-02-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210491-002	ODE-247	2026-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210491-002	ODE-335	2027-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210491-001	ODE-173	2025-02-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210491-001	ODE-247	2026-06-21	`2680178bc6a6…`

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1243046	Internal RxNorm lookup
1999387	Internal RxNorm lookup
1999388	Internal RxNorm lookup
1999389	Internal RxNorm lookup
2174387	Internal RxNorm lookup
2174388	Internal RxNorm lookup
2174389	Internal RxNorm lookup
2174390	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
302ae804-37db-44fd-ac2f-3dbdeda9aa4b	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

FDA-Initiated Inactive NDC Indexing#

Related label table
Related label
These highlights do not include all the information needed to use SYMDEKO safely and effectively. See full prescribing information for SYMDEKO. SYMDEKO ® (tezacaftor/ivacaftor) tablets; (ivacaftor) tablets, for oral use Initial U.S. Approval: 2018
These highlights do not include all the information needed to use SYMDEKO safely and effectively. See full prescribing information for SYMDEKO. SYMDEKO ® (tezacaftor/ivacaftor) tablets; (ivacaftor) tablets, for oral use Initial U.S. Approval: 2018
These highlights do not include all the information needed to use SYMDEKO safely and effectively. See full prescribing information for SYMDEKO. SYMDEKO ® (tezacaftor/ivacaftor) tablets; (ivacaftor) tablets, for oral use Initial U.S. Approval: 2018
These highlights do not include all the information needed to use SYMDEKO safely and effectively. See full prescribing information for SYMDEKO. SYMDEKO ® (tezacaftor/ivacaftor) tablets; (ivacaftor) tablets, for oral use Initial U.S. Approval: 2018

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51167-661-01	SYMDEKO	1 in 1 CARTON	KIT	1		21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51167-661-01	EA - Each	51167-661	0d1d0678-0648-477d-980e-e5a19dc46ddf	1	2018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51167-661	SYMDEKO (TEZACAFTOR AND IVACAFTOR) KIT [VERTEX PHARMACEUTICALS INCORPORATED]	19	Current NDC, Legacy NDC, 1 package rows	20250227_302ae804-37db-44fd-ac2f-3dbdeda9aa4b.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
SYMDEKO	TEZACAFTOR AND IVACAFTOR	Vertex Pharmaceuticals Incorporated	302ae804-37db-44fd-ac2f-3dbdeda9aa4b	2026-08-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210491 application number: NDA210491 ndc (product): 51167-661

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1999389	{28 (ivacaftor 150 MG / tezacaftor 100 MG Oral Tablet) / 28 (ivacaftor 150 MG Oral Tablet) } Pack [Symdeko (100 MG / 150 MG; 150 MG)]	BPCK	302ae804-37db-44fd-ac2f-3dbdeda9aa4b	21
2174390	{28 (ivacaftor 75 MG / tezacaftor 50 MG Oral Tablet) / 28 (ivacaftor 75 MG Oral Tablet) } Pack [Symdeko (50 MG / 75 MG; 75 MG)]	BPCK	302ae804-37db-44fd-ac2f-3dbdeda9aa4b	21
1999388	{28 (ivacaftor 150 MG / tezacaftor 100 MG Oral Tablet) / 28 (ivacaftor 150 MG Oral Tablet) } Pack	GPCK	302ae804-37db-44fd-ac2f-3dbdeda9aa4b	21
2174389	{28 (ivacaftor 75 MG / tezacaftor 50 MG Oral Tablet) / 28 (ivacaftor 75 MG Oral Tablet) } Pack	GPCK	302ae804-37db-44fd-ac2f-3dbdeda9aa4b	21
1999388	ivacaftor 150 MG / tezacaftor 100 MG (28) Oral Tablet / ivacaftor 150 MG (28) Oral Tablet Pack	PSN	302ae804-37db-44fd-ac2f-3dbdeda9aa4b	21
1999387	ivacaftor 150 MG / tezacaftor 100 MG Oral Tablet	PSN	302ae804-37db-44fd-ac2f-3dbdeda9aa4b	21
1243046	ivacaftor 150 MG Oral Tablet	PSN	302ae804-37db-44fd-ac2f-3dbdeda9aa4b	21
2174389	ivacaftor 75 MG / tezacaftor 50 MG (28) Oral Tablet / ivacaftor 75 MG (28) Oral Tablet Pack	PSN	302ae804-37db-44fd-ac2f-3dbdeda9aa4b	21
2174387	ivacaftor 75 MG / tezacaftor 50 MG Oral Tablet	PSN	302ae804-37db-44fd-ac2f-3dbdeda9aa4b	21
2174388	ivacaftor 75 MG Oral Tablet	PSN	302ae804-37db-44fd-ac2f-3dbdeda9aa4b	21
1999389	symdeko 100 MG / 150 MG and 150 MG Pack	PSN	302ae804-37db-44fd-ac2f-3dbdeda9aa4b	21
2174390	symdeko 50 MG / 75 MG and 75 MG Pack	PSN	302ae804-37db-44fd-ac2f-3dbdeda9aa4b	21
1999387	ivacaftor 150 MG / tezacaftor 100 MG Oral Tablet	SCD	302ae804-37db-44fd-ac2f-3dbdeda9aa4b	21
1243046	ivacaftor 150 MG Oral Tablet	SCD	302ae804-37db-44fd-ac2f-3dbdeda9aa4b	21
2174387	ivacaftor 75 MG / tezacaftor 50 MG Oral Tablet	SCD	302ae804-37db-44fd-ac2f-3dbdeda9aa4b	21
2174388	ivacaftor 75 MG Oral Tablet	SCD	302ae804-37db-44fd-ac2f-3dbdeda9aa4b	21
1999388	ivacaftor 150 MG / tezacaftor 100 MG (28) Oral Tablet / ivacaftor 150 MG (28) Oral Tablet Pack	SY	302ae804-37db-44fd-ac2f-3dbdeda9aa4b	21
2174389	ivacaftor 75 MG / tezacaftor 50 MG (28) Oral Tablet / ivacaftor 75 MG (28) Oral Tablet Pack	SY	302ae804-37db-44fd-ac2f-3dbdeda9aa4b	21
1999389	symdeko 100 MG / 150 MG and 150 MG Pack	SY	302ae804-37db-44fd-ac2f-3dbdeda9aa4b	21
2174390	symdeko 50 MG / 75 MG and 75 MG Pack	SY	302ae804-37db-44fd-ac2f-3dbdeda9aa4b	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51167-661-01	51167066101	1 KIT in 1 CARTON (51167-661-01) * 7 TABLET, FILM COATED in 1 BLISTER PACK * 7 TABLET, FILM COATED in 1 BLISTER PACK	1 kit	2018-02-12	0000-00-00	No	No	Current