CHOLBAM

Product NDC: 79378-001
11-digit product format: 793780001
Labeler code: 79378
Product ID: 79378-001_edddbf7e-e2dd-4ff7-80a0-d73c22fd40ce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cholic acid
Dosage form: CAPSULE
Route: ORAL
Labeler: Mirum Pharmaceuticals Inc.
Application: NDA205750
Marketing category: NDA
Marketing start: 2025-05-09
Substance: CHOLIC ACID
Active strength: 50 mg/1
Pharmacologic classes: Bile Acid [EPC], Bile Acids and Salts [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 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
N205750-001	CHOLBAM	CHOLIC ACID	50MG	CAPSULE / ORAL		RLD	2015-03-17
N205750-002	CHOLBAM	CHOLIC ACID	250MG	CAPSULE / ORAL		RLD, RS	2015-03-17

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 · 84 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	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`bb7c543d1eb4…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 48 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	N205750-001	ODE-91	2022-03-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205750-002	ODE-91	2022-03-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205750-001	ODE-91	2022-03-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N205750-002	ODE-91	2022-03-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205750-001	ODE-91	2022-03-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N205750-002	ODE-91	2022-03-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205750-001	NCE	2020-03-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205750-001	ODE-91	2022-03-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205750-002	NCE	2020-03-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205750-002	ODE-91	2022-03-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205750-001	ODE-91	2022-03-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N205750-002	ODE-91	2022-03-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205750-001	ODE-91	2022-03-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N205750-002	ODE-91	2022-03-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205750-001	ODE-91	2022-03-17	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205750-002	ODE-91	2022-03-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205750-001	ODE-91	2022-03-17	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N205750-002	ODE-91	2022-03-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205750-001	NCE	2020-03-17	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205750-001	ODE-91	2022-03-17	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205750-002	NCE	2020-03-17	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205750-002	ODE-91	2022-03-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205750-001	NCE	2020-03-17	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205750-001	ODE-91	2022-03-17	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205750-002	NCE	2020-03-17	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205750-002	ODE-91	2022-03-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205750-001	NCE	2020-03-17	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205750-001	ODE-91	2022-03-17	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205750-002	NCE	2020-03-17	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205750-002	ODE-91	2022-03-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205750-001	NCE	2020-03-17	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205750-001	ODE-91	2022-03-17	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205750-002	NCE	2020-03-17	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205750-002	ODE-91	2022-03-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205750-001	NCE	2020-03-17	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N205750-001	ODE-91	2022-03-17	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N205750-002	NCE	2020-03-17	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N205750-002	ODE-91	2022-03-17	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N205750-001	ODE-91	2022-03-17	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N205750-002	ODE-91	2022-03-17	`3bdfa0b2c4d7…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHOLIC ACID	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G1JO7801AE	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1440861	Internal RxNorm lookup
1440868	Internal RxNorm lookup
1608274	Internal RxNorm lookup
1608276	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
5c6e4c9d-b85e-493f-9420-ab2fd0ff3723	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f99d8137-bd66-44a7-97c0-687c5d02cfc7	Product name	1	20150417

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
79378-001-02	CHOLBAM	90 in 1 BOTTLE	CAPSULE	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
79378-001-02	EA - Each	79378-001	b0d71bcb-e32d-4421-9caa-fe99d23fc3e7	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79378-001	CHOLBAM (CHOLIC ACID) CAPSULE [MIRUM PHARMACEUTICALS INC.]	1	Current NDC, 1 package rows	20250509_5c6e4c9d-b85e-493f-9420-ab2fd0ff3723.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
CHOLBAM	CHOLIC ACID	Mirum Pharmaceuticals Inc.	5c6e4c9d-b85e-493f-9420-ab2fd0ff3723	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205750 application number: NDA205750 ndc (product): 79378-001

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G1JO7801AE	CHOLIC ACID	81-25-4	CHOLIC ACID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1608274	Cholbam 250 MG Oral Capsule	PSN	5c6e4c9d-b85e-493f-9420-ab2fd0ff3723	2
1608276	Cholbam 50 MG Oral Capsule	PSN	5c6e4c9d-b85e-493f-9420-ab2fd0ff3723	2
1440861	cholic acid 250 MG Oral Capsule	PSN	5c6e4c9d-b85e-493f-9420-ab2fd0ff3723	2
1440868	cholic acid 50 MG Oral Capsule	PSN	5c6e4c9d-b85e-493f-9420-ab2fd0ff3723	2
1608274	cholic acid 250 MG Oral Capsule [Cholbam]	SBD	5c6e4c9d-b85e-493f-9420-ab2fd0ff3723	2
1608276	cholic acid 50 MG Oral Capsule [Cholbam]	SBD	5c6e4c9d-b85e-493f-9420-ab2fd0ff3723	2
1440861	cholic acid 250 MG Oral Capsule	SCD	5c6e4c9d-b85e-493f-9420-ab2fd0ff3723	2
1440868	cholic acid 50 MG Oral Capsule	SCD	5c6e4c9d-b85e-493f-9420-ab2fd0ff3723	2
1608274	Cholbam 250 MG Oral Capsule	SY	5c6e4c9d-b85e-493f-9420-ab2fd0ff3723	2
1608276	Cholbam 50 MG Oral Capsule	SY	5c6e4c9d-b85e-493f-9420-ab2fd0ff3723	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
79378-001-02	79378000102	90 CAPSULE in 1 BOTTLE (79378-001-02)	90 capsule	2025-05-09	No	No	Current