Ocaliva

Product NDC: 69516-005
Requested package NDC: 69516-005-30
11-digit product format: 695160005
Labeler code: 69516
Product ID: 69516-005_1d6c9e9d-e17d-4609-91fa-75e5bdbc5114
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Obeticholic Acid
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Intercept Pharmaceuticals Inc
Application: NDA207999
Marketing category: NDA
Marketing start: 2016-05-27
Marketing end: 0000-00-00
Substance: OBETICHOLIC ACID
Active strength: 5 mg/1
Pharmacologic classes: Farnesoid X Receptor Agonist [EPC], Farnesoid X Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69516-005	69516-005-30	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69516-005	69516-005-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
N207999-001	OCALIVA	OBETICHOLIC ACID	5MG	TABLET / ORAL		RLD	2016-05-27
N207999-002	OCALIVA	OBETICHOLIC ACID	10MG	TABLET / ORAL		RLD	2016-05-27

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207999-001	RE48286	2027-02-21		Drug substance, Drug product	2020-10-28
N207999-001	10174073	2033-06-17		Drug substance	2019-01-15
N207999-001	9238673	2033-06-17		Drug product	2016-06-22
N207999-001	10047117	2033-09-06	U-1854		2018-11-14
N207999-001	10052337	2036-04-26		Drug product	2018-11-08
N207999-001	10751349	2036-04-26		Drug product	2020-08-28
N207999-001	10758549	2036-04-26	U-2945		2020-09-10
N207999-002	RE48286	2027-02-21		Drug substance, Drug product	2020-10-28
N207999-002	10174073	2033-06-17		Drug substance	2019-01-15
N207999-002	9238673	2033-06-17		Drug product	2016-06-22
N207999-002	10047117	2033-09-06	U-1854		2018-11-14
N207999-002	10052337	2036-04-26		Drug product	2018-11-08
N207999-002	10751349	2036-04-26		Drug product	2020-08-28
N207999-002	10758549	2036-04-26	U-2945		2020-09-10

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 · 86 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	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD	2016-05-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD	2016-05-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD	2016-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD	2016-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207999-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207999-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207999-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207999-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N207999-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N207999-002	AB	1	`3f0d92c62455…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 684 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	N207999-001	RE48286	2027-02-21		Drug substance, Drug product	2020-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207999-001	10174073	2033-06-17		Drug substance	2019-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207999-001	9238673	2033-06-17		Drug product	2016-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207999-001	10047117	2033-09-06	U-1854		2018-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207999-001	10052337	2036-04-26		Drug product	2018-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207999-001	10751349	2036-04-26		Drug product	2020-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207999-001	10758549	2036-04-26	U-2945		2020-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207999-002	RE48286	2027-02-21		Drug substance, Drug product	2020-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207999-002	10174073	2033-06-17		Drug substance	2019-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207999-002	9238673	2033-06-17		Drug product	2016-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207999-002	10047117	2033-09-06	U-1854		2018-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207999-002	10052337	2036-04-26		Drug product	2018-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207999-002	10751349	2036-04-26		Drug product	2020-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207999-002	10758549	2036-04-26	U-2945		2020-09-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N207999-001	RE48286	2027-02-21		Drug substance, Drug product	2020-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207999-001	10174073	2033-06-17		Drug substance	2019-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207999-001	9238673	2033-06-17		Drug product	2016-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207999-001	10047117	2033-09-06	U-1854		2018-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207999-001	10052337	2036-04-26		Drug product	2018-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207999-001	10751349	2036-04-26		Drug product	2020-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207999-001	10758549	2036-04-26	U-2945		2020-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207999-002	RE48286	2027-02-21		Drug substance, Drug product	2020-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207999-002	10174073	2033-06-17		Drug substance	2019-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207999-002	9238673	2033-06-17		Drug product	2016-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207999-002	10047117	2033-09-06	U-1854		2018-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207999-002	10052337	2036-04-26		Drug product	2018-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207999-002	10751349	2036-04-26		Drug product	2020-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207999-002	10758549	2036-04-26	U-2945		2020-09-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207999-001	RE48286	2027-02-21		Drug substance, Drug product	2020-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207999-001	10174073	2033-06-17		Drug substance	2019-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207999-001	9238673	2033-06-17		Drug product	2016-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207999-001	10047117	2033-09-06	U-1854		2018-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207999-001	10052337	2036-04-26		Drug product	2018-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207999-001	10751349	2036-04-26		Drug product	2020-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207999-001	10758549	2036-04-26	U-2945		2020-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207999-002	RE48286	2027-02-21		Drug substance, Drug product	2020-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207999-002	10174073	2033-06-17		Drug substance	2019-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207999-002	9238673	2033-06-17		Drug product	2016-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207999-002	10047117	2033-09-06	U-1854		2018-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207999-002	10052337	2036-04-26		Drug product	2018-11-08	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207999-001	ODE-119	2023-05-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207999-002	ODE-119	2023-05-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207999-001	ODE-119	2023-05-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207999-002	ODE-119	2023-05-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207999-001	ODE-119	2023-05-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207999-002	ODE-119	2023-05-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207999-001	NCE	2021-05-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207999-001	ODE-119	2023-05-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207999-002	NCE	2021-05-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207999-002	ODE-119	2023-05-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207999-001	ODE-119	2023-05-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N207999-002	ODE-119	2023-05-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207999-001	NCE	2021-05-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207999-001	ODE-119	2023-05-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207999-002	NCE	2021-05-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207999-002	ODE-119	2023-05-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207999-001	NCE	2021-05-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207999-001	ODE-119	2023-05-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207999-002	NCE	2021-05-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207999-002	ODE-119	2023-05-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207999-001	NCE	2021-05-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N207999-001	ODE-119	2023-05-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N207999-002	NCE	2021-05-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N207999-002	ODE-119	2023-05-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207999-001	NCE	2021-05-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207999-001	ODE-119	2023-05-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207999-002	NCE	2021-05-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207999-002	ODE-119	2023-05-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207999-001	NCE	2021-05-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207999-001	ODE-119	2023-05-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207999-002	NCE	2021-05-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207999-002	ODE-119	2023-05-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207999-001	NCE	2021-05-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207999-001	ODE-119	2023-05-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207999-002	NCE	2021-05-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207999-002	ODE-119	2023-05-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207999-001	NCE	2021-05-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207999-001	ODE-119	2023-05-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207999-002	NCE	2021-05-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207999-002	ODE-119	2023-05-27	`b00525d2431f…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
aa00e97b-8a09-4ebf-9af7-44b2ba90feee	Product name	1	20160714
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69516-005-30	2020-07-22	C162847	48780-1	ab0e2407-280a-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use OCALIVA ® safely and effectively. See full prescribing information for OCALIVA. OCALIVA ® (obeticholic acid) tablets, for oral use Initial U.S. Approval: 2016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69516-005-30	EA - Each	69516-005	ff3581c4-8326-4097-9dbb-20f432abb58e	1	2016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69516-005	OCALIVA (OBETICHOLIC ACID) TABLET, FILM COATED [INTERCEPT PHARMACEUTICALS INC]	13	Legacy NDC	20241109_cdfbe0cd-eb15-45a1-ac17-531bcda21aec.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0462Z4S4OZ	OBETICHOLIC ACID	459789-99-2	OBETICHOLIC ACID

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69516-005-30	69516000530	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69516-005-30)	2016-05-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ocaliva	Intercept Pharmaceuticals Inc \| Piramal Healthcare UK Limited	2024-11-07	HUMAN PRESCRIPTION DRUG LABEL	13