Talicia

Product NDC: 57841-1150
11-digit product format: 578411150
Labeler code: 57841
Product ID: 57841-1150_0649301c-fc4e-42a4-a62d-9a023a3f9f98
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: omeprazole magnesium, amoxicillin and rifabutin
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: RedHill Biopharma Ltd
Application: NDA213004
Marketing category: NDA
Marketing start: 2020-03-09
Substance: OMEPRAZOLE MAGNESIUM; AMOXICILLIN; RIFABUTIN
Active strength: 10; 250; 12.5 mg/1; mg/1; mg/1
Pharmacologic classes: Cytochrome P450 2C19 Inhibitors [MoA], Penicillin-class Antibacterial [EPC], Penicillins [CS], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA], Rifamycin Antimycobacterial [EPC], Rifamycins [CS]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N213004-001	TALICIA	AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-11-01

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213004-001	10238606	2034-02-12		Drug product	2019-11-25
N213004-001	11135172	2034-02-12	U-2660	Drug product	2021-10-07
N213004-001	11931463	2034-02-12	U-3866	Drug product	2024-04-04
N213004-001	9050263	2034-02-12	U-2660	Drug product	2019-11-25
N213004-001	9498445	2034-02-12	U-2660	Drug product	2019-11-25
N213004-001	9603806	2034-02-12	U-2660	Drug product	2019-11-25
N213004-001	11878011	2042-05-27	U-3816		2024-02-21

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N213004-001	NP	2022-11-01
N213004-001	GAIN	2027-11-01

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
2026-09-14 22:38:34	2026-08	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 230 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	N213004-001	10238606	2034-02-12		Drug product	2019-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213004-001	11135172	2034-02-12	U-2660	Drug product	2021-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213004-001	11931463	2034-02-12	U-3866	Drug product	2024-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213004-001	9050263	2034-02-12	U-2660	Drug product	2019-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213004-001	9498445	2034-02-12	U-2660	Drug product	2019-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213004-001	9603806	2034-02-12	U-2660	Drug product	2019-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213004-001	11878011	2042-05-27	U-3816		2024-02-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213004-001	10238606	2034-02-12		Drug product	2019-11-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213004-001	11135172	2034-02-12	U-2660	Drug product	2021-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213004-001	11931463	2034-02-12	U-3866	Drug product	2024-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213004-001	9050263	2034-02-12	U-2660	Drug product	2019-11-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213004-001	9498445	2034-02-12	U-2660	Drug product	2019-11-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213004-001	9603806	2034-02-12	U-2660	Drug product	2019-11-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213004-001	11878011	2042-05-27	U-3816		2024-02-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213004-001	10238606	2034-02-12		Drug product	2019-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213004-001	11135172	2034-02-12	U-2660	Drug product	2021-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213004-001	11931463	2034-02-12	U-3866	Drug product	2024-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213004-001	9050263	2034-02-12	U-2660	Drug product	2019-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213004-001	9498445	2034-02-12	U-2660	Drug product	2019-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213004-001	9603806	2034-02-12	U-2660	Drug product	2019-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213004-001	11878011	2042-05-27	U-3816		2024-02-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213004-001	10238606	2034-02-12		Drug product	2019-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213004-001	11135172	2034-02-12	U-2660	Drug product	2021-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213004-001	11931463	2034-02-12	U-3866	Drug product	2024-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213004-001	9050263	2034-02-12	U-2660	Drug product	2019-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213004-001	9498445	2034-02-12	U-2660	Drug product	2019-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213004-001	9603806	2034-02-12	U-2660	Drug product	2019-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213004-001	11878011	2042-05-27	U-3816		2024-02-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213004-001	10238606	2034-02-12		Drug product	2019-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213004-001	11135172	2034-02-12	U-2660	Drug product	2021-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213004-001	11931463	2034-02-12	U-3866	Drug product	2024-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213004-001	9050263	2034-02-12	U-2660	Drug product	2019-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213004-001	9498445	2034-02-12	U-2660	Drug product	2019-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213004-001	9603806	2034-02-12	U-2660	Drug product	2019-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213004-001	11878011	2042-05-27	U-3816		2024-02-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213004-001	10238606	2034-02-12		Drug product	2019-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213004-001	11135172	2034-02-12	U-2660	Drug product	2021-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213004-001	11931463	2034-02-12	U-3866	Drug product	2024-04-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213004-001	9050263	2034-02-12	U-2660	Drug product	2019-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213004-001	9498445	2034-02-12	U-2660	Drug product	2019-11-25	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 42 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	N213004-001	NP	2022-11-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213004-001	GAIN	2027-11-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213004-001	NP	2022-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213004-001	GAIN	2027-11-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213004-001	NP	2022-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213004-001	GAIN	2027-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213004-001	NP	2022-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213004-001	GAIN	2027-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213004-001	NP	2022-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213004-001	GAIN	2027-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213004-001	NP	2022-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213004-001	GAIN	2027-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213004-001	NP	2022-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213004-001	GAIN	2027-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213004-001	NP	2022-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213004-001	GAIN	2027-11-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213004-001	NP	2022-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213004-001	GAIN	2027-11-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213004-001	NP	2022-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213004-001	GAIN	2027-11-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213004-001	NP	2022-11-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213004-001	GAIN	2027-11-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213004-001	NP	2022-11-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213004-001	GAIN	2027-11-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213004-001	NP	2022-11-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213004-001	GAIN	2027-11-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213004-001	NP	2022-11-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213004-001	GAIN	2027-11-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213004-001	NP	2022-11-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213004-001	GAIN	2027-11-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213004-001	NP	2022-11-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N213004-001	GAIN	2027-11-01	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213004-001	NP	2022-11-01	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213004-001	GAIN	2027-11-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213004-001	NP	2022-11-01	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N213004-001	GAIN	2027-11-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213004-001	NP	2022-11-01	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N213004-001	GAIN	2027-11-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213004-001	NP	2022-11-01	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213004-001	GAIN	2027-11-01	`a72a2bbeb626…`

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: Talicia
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OMEPRAZOLE MAGNESIUM	10 mg/1
AMOXICILLIN	250 mg/1
RIFABUTIN	12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
426QFE7XLK	Internal UNII lookup
804826J2HU	Internal UNII lookup
1W306TDA6S	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2262026	Internal RxNorm lookup
2262032	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
68c4e9dc-dbcf-4151-b6f7-5e4b9922b76f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
502415e5-4ac7-4266-a01a-ef44aa3c028d	Product name	7	20250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0f	Product name	3	20250620
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
2ebbc361-d28f-48a9-a286-c1ae09cdaf5c	Product name	3	20230314
2bb254ff-3d7f-4bdb-abf9-476506008c55	Product name	1	20230117
873ef493-6b37-49d8-ac7f-bfca4117d2c1	Product name	5	20210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
8690a824-4bf8-4d1e-b118-2d6dda86bc04	Product name	2	20161206
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
48b3639b-9f6e-fb03-0720-42e7d1e139ac	Product name	1	20140508
cf3f1c02-1f32-2322-3314-b70ebbf5610e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57841-1150-1	Talicia	84 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	84	10
57841-1150-2	Talicia	2 in 1 CARTON	CAPSULE, DELAYED RELEASE	2	10
57841-1150-3	Talicia	84 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	84	10
57841-1150-4	Talicia	2 in 1 CARTON	CAPSULE, DELAYED RELEASE	2	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57841-1150-1	EA - Each	57841-1150	3b3054f0-cc1a-4210-a436-956aee889ff1	1	2020-01-03
57841-1150-2	EA - Each	57841-1150	602aed7c-b46a-414d-8b76-1b910d596a69	1	2020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57841-1150	TALICIA (OMEPRAZOLE MAGNESIUM, AMOXICILLIN AND RIFABUTIN) CAPSULE, DELAYED RELEASE [REDHILL BIOPHARMA LTD]	9	Current NDC, Legacy NDC, 4 package rows	20240503_68c4e9dc-dbcf-4151-b6f7-5e4b9922b76f.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
Talicia	OMEPRAZOLE MAGNESIUM, AMOXICILLIN AND RIFABUTIN	RedHill Biopharma Ltd	68c4e9dc-dbcf-4151-b6f7-5e4b9922b76f	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213004 application number: NDA213004 ndc (product): 57841-1150

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
426QFE7XLK	OMEPRAZOLE MAGNESIUM	95382-33-5	OMEPRAZOLE MAGNESIUM
804826J2HU	AMOXICILLIN	61336-70-7	AMOXICILLIN
1W306TDA6S	RIFABUTIN	72559-06-9	RIFABUTIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2262026	amoxicillin 250 MG / omeprazole 10 MG / rifabutin 12.5 MG Delayed Release Oral Capsule	PSN	68c4e9dc-dbcf-4151-b6f7-5e4b9922b76f	10
2262032	TALICIA 250 MG / 10 MG / 12.5 MG Delayed Release Oral Capsule	PSN	68c4e9dc-dbcf-4151-b6f7-5e4b9922b76f	10
2262032	amoxicillin 250 MG / omeprazole 10 MG / rifabutin 12.5 MG Delayed Release Oral Capsule [Talicia]	SBD	68c4e9dc-dbcf-4151-b6f7-5e4b9922b76f	10
2262026	amoxicillin 250 MG / omeprazole 10 MG / rifabutin 12.5 MG Delayed Release Oral Capsule	SCD	68c4e9dc-dbcf-4151-b6f7-5e4b9922b76f	10
2262032	Talicia 250 MG / 10 MG / 12.5 MG Delayed Release Oral Capsule	SY	68c4e9dc-dbcf-4151-b6f7-5e4b9922b76f	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57841-1150-1	57841115001	84 in 1 BOTTLE						Historical
57841-1150-2	57841115002	2 BOTTLE in 1 CARTON (57841-1150-2) / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-1)	2 bottle	2020-03-09	0000-00-00	No	No	Current
57841-1150-3	57841115003	84 in 1 BOTTLE						Historical
57841-1150-4	57841115004	2 BOTTLE in 1 CARTON (57841-1150-4) / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-3)	2 bottle	2021-09-24	0000-00-00	Yes	No	Current