SIRTURO

Product NDC: 59676-701
11-digit product format: 596760701
Labeler code: 59676
Product ID: 59676-701_415acee9-3121-56fb-e063-6394a90a9d83
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bedaquiline Fumarate
Dosage form: TABLET
Route: ORAL
Labeler: Janssen Products, LP
Application: NDA204384
Marketing category: NDA
Marketing start: 2012-12-28
Substance: BEDAQUILINE FUMARATE
Active strength: 100 mg/1
Pharmacologic classes: Diarylquinoline Antimycobacterial [EPC], Diarylquinolines [CS]
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 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
N204384-001	SIRTURO	BEDAQUILINE FUMARATE	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2012-12-28
N204384-002	SIRTURO	BEDAQUILINE FUMARATE	EQ 20MG BASE	TABLET / ORAL		RLD	2020-05-27

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204384-001	7498343	2026-12-01	U-1321	Drug substance, Drug product	2013-01-24
N204384-001	8546428	2029-03-19	U-1321	Drug substance, Drug product	2014-03-14
N204384-002	7498343	2026-12-01	U-1321	Drug substance, Drug product	2020-06-24
N204384-002	8546428	2029-03-19	U-1321	Drug substance, Drug product	2020-06-24

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 8 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N204384-001	ODE-251	2026-08-09
N204384-001	ODE-307	2027-05-27
N204384-001	M-306	2027-06-21
N204384-001	NPP	2028-07-28
N204384-002	ODE*	2026-08-09
N204384-002	ODE-307	2027-05-27
N204384-002	M-306	2027-06-21
N204384-002	NPP	2028-07-28

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 · 82 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	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 164 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	N204384-001	7498343	2026-12-01	U-1321	Drug substance, Drug product	2013-01-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204384-001	8546428	2029-03-19	U-1321	Drug substance, Drug product	2014-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204384-002	7498343	2026-12-01	U-1321	Drug substance, Drug product	2020-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204384-002	8546428	2029-03-19	U-1321	Drug substance, Drug product	2020-06-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204384-001	7498343	2026-12-01	U-1321	Drug substance, Drug product	2013-01-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204384-001	8546428	2029-03-19	U-1321	Drug substance, Drug product	2014-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204384-002	7498343	2026-12-01	U-1321	Drug substance, Drug product	2020-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204384-002	8546428	2029-03-19	U-1321	Drug substance, Drug product	2020-06-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204384-001	7498343	2026-12-01	U-1321	Drug substance, Drug product	2013-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204384-001	8546428	2029-03-19	U-1321	Drug substance, Drug product	2014-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204384-002	7498343	2026-12-01	U-1321	Drug substance, Drug product	2020-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204384-002	8546428	2029-03-19	U-1321	Drug substance, Drug product	2020-06-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204384-001	7498343	2026-12-01	U-1321	Drug substance, Drug product	2013-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204384-001	8546428	2029-03-19	U-1321	Drug substance, Drug product	2014-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204384-002	7498343	2026-12-01	U-1321	Drug substance, Drug product	2020-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204384-002	8546428	2029-03-19	U-1321	Drug substance, Drug product	2020-06-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204384-001	7498343	2026-12-01	U-1321	Drug substance, Drug product	2013-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204384-001	8546428	2029-03-19	U-1321	Drug substance, Drug product	2014-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204384-002	7498343	2026-12-01	U-1321	Drug substance, Drug product	2020-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204384-002	8546428	2029-03-19	U-1321	Drug substance, Drug product	2020-06-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204384-001	7498343	2026-12-01	U-1321	Drug substance, Drug product	2013-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204384-001	8546428	2029-03-19	U-1321	Drug substance, Drug product	2014-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204384-002	7498343	2026-12-01	U-1321	Drug substance, Drug product	2020-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204384-002	8546428	2029-03-19	U-1321	Drug substance, Drug product	2020-06-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204384-001	7498343	2026-12-01	U-1321	Drug substance, Drug product	2013-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204384-001	8546428	2029-03-19	U-1321	Drug substance, Drug product	2014-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204384-002	7498343	2026-12-01	U-1321	Drug substance, Drug product	2020-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204384-002	8546428	2029-03-19	U-1321	Drug substance, Drug product	2020-06-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204384-001	7498343	2026-12-01	U-1321	Drug substance, Drug product	2013-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204384-001	8546428	2029-03-19	U-1321	Drug substance, Drug product	2014-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204384-002	7498343	2026-12-01	U-1321	Drug substance, Drug product	2020-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204384-002	8546428	2029-03-19	U-1321	Drug substance, Drug product	2020-06-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204384-001	7498343	2026-12-01	U-1321	Drug substance, Drug product	2013-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204384-001	8546428	2029-03-19	U-1321	Drug substance, Drug product	2014-03-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204384-002	7498343	2026-12-01	U-1321	Drug substance, Drug product	2020-06-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204384-002	8546428	2029-03-19	U-1321	Drug substance, Drug product	2020-06-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204384-001	7498343	2026-12-01	U-1321	Drug substance, Drug product	2013-01-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204384-001	8546428	2029-03-19	U-1321	Drug substance, Drug product	2014-03-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204384-002	7498343	2026-12-01	U-1321	Drug substance, Drug product	2020-06-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204384-002	8546428	2029-03-19	U-1321	Drug substance, Drug product	2020-06-24	`5bbf6a4d5a75…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 176 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	N204384-001	ODE-251	2026-08-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204384-001	ODE-307	2027-05-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204384-001	M-306	2027-06-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204384-001	NPP	2028-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204384-002	ODE*	2026-08-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204384-002	ODE-307	2027-05-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204384-002	M-306	2027-06-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204384-002	NPP	2028-07-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204384-001	ODE-251	2026-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204384-001	ODE-307	2027-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204384-001	M-306	2027-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204384-002	ODE*	2026-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204384-002	ODE-307	2027-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204384-002	M-306	2027-06-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204384-001	ODE-251	2026-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204384-001	ODE-307	2027-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204384-001	M-306	2027-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204384-002	ODE*	2026-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204384-002	ODE-307	2027-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204384-002	M-306	2027-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204384-001	ODE-251	2026-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204384-001	ODE-307	2027-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204384-001	M-306	2027-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204384-002	ODE*	2026-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204384-002	ODE-307	2027-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204384-002	M-306	2027-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204384-001	ODE-251	2026-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204384-001	ODE-307	2027-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204384-001	M-306	2027-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204384-002	ODE*	2026-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204384-002	ODE-307	2027-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204384-002	M-306	2027-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204384-001	ODE-251	2026-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204384-001	ODE-307	2027-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204384-001	M-306	2027-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204384-002	ODE-307	2027-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204384-002	M-306	2027-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204384-001	ODE-251	2026-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204384-001	ODE-307	2027-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204384-001	M-306	2027-06-21	`b8a1b40f171c…`

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: SIRTURO
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BEDAQUILINE FUMARATE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
P04QX2C1A5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1364509	Internal RxNorm lookup
1364515	Internal RxNorm lookup
2373939	Internal RxNorm lookup
2373941	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
1534c9ae-4948-4cf4-9f66-222a99db6d0e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
91496dbd-18e1-6892-8e92-13b75981d3f2	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59676-701-01	SIRTURO	188 in 1 BOTTLE	TABLET	188		33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59676-701-01	EA - Each	59676-701	7778105e-e2fb-46f2-b8b6-26d84e656e65	1	2013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Bedaquiline Fumarate	ACTIVE INGREDIENT	P04QX2C1A5	SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]	8
Bedaquiline	ACTIVE MOIETY	78846I289Y	SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]	8
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]	8
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]	8
hypromellose 2910 (15 mPa.s)	INACTIVE INGREDIENT	36SFW2JZ0W	SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]	8
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]	8
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]	8
polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]	8
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]	8
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]	8
water	INACTIVE INGREDIENT	059QF0KO0R	SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59676-701	SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]	28	Current NDC, Legacy NDC, 1 package rows	20240802_1534c9ae-4948-4cf4-9f66-222a99db6d0e.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
SIRTURO	BEDAQUILINE FUMARATE	Janssen Products, LP	1534c9ae-4948-4cf4-9f66-222a99db6d0e	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204384 application number: NDA204384 ndc (product): 59676-701

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
P04QX2C1A5	BEDAQUILINE FUMARATE	845533-86-0	BEDAQUILINE FUMARATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1364509	bedaquiline 100 MG Oral Tablet	PSN	1534c9ae-4948-4cf4-9f66-222a99db6d0e	33
2373939	bedaquiline 20 MG Oral Tablet	PSN	1534c9ae-4948-4cf4-9f66-222a99db6d0e	33
1364515	Sirturo 100 MG Oral Tablet	PSN	1534c9ae-4948-4cf4-9f66-222a99db6d0e	33
2373941	Sirturo 20 MG Oral Tablet	PSN	1534c9ae-4948-4cf4-9f66-222a99db6d0e	33
1364515	bedaquiline 100 MG Oral Tablet [Sirturo]	SBD	1534c9ae-4948-4cf4-9f66-222a99db6d0e	33
2373941	bedaquiline 20 MG Oral Tablet [Sirturo]	SBD	1534c9ae-4948-4cf4-9f66-222a99db6d0e	33
1364509	bedaquiline 100 MG Oral Tablet	SCD	1534c9ae-4948-4cf4-9f66-222a99db6d0e	33
2373939	bedaquiline 20 MG Oral Tablet	SCD	1534c9ae-4948-4cf4-9f66-222a99db6d0e	33
1364509	bedaquiline 100 MG (as bedaquiline fumarate 120.9 MG) Oral Tablet	SY	1534c9ae-4948-4cf4-9f66-222a99db6d0e	33
2373939	bedaquiline 20 MG (as bedaquiline fumarate 24.18 MG) Oral Tablet	SY	1534c9ae-4948-4cf4-9f66-222a99db6d0e	33
1364515	Sirturo 100 MG (as bedaquiline fumarate 120.9 MG) Oral Tablet	SY	1534c9ae-4948-4cf4-9f66-222a99db6d0e	33
1364515	Sirturo 100 MG Oral Tablet	SY	1534c9ae-4948-4cf4-9f66-222a99db6d0e	33
2373941	Sirturo 20 MG (as bedaquiline fumarate 24.18 MG) Oral Tablet	SY	1534c9ae-4948-4cf4-9f66-222a99db6d0e	33
2373941	Sirturo 20 MG Oral Tablet	SY	1534c9ae-4948-4cf4-9f66-222a99db6d0e	33

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59676-701-01	59676070101	188 TABLET in 1 BOTTLE (59676-701-01)	188 tablet	2012-12-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SIRTURO	Janssen Products, LP \| Janssen Pharmaceutica NV \| Carbogen Amcis AG \| Cilag AG \| Porton Pharma Solutions Ltd \| Recipharm Pharmaservices Private Limited \| Dishman Carbogen Amcis Limited	2025-10-17	HUMAN PRESCRIPTION DRUG LABEL	33