Cholbam

Product NDC: 45043-001
Requested package NDC: 45043-001-02
11-digit product format: 450430001
Labeler code: 45043
Product ID: 45043-001_83e385b7-54bc-4ee2-b477-4e7524508ee3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cholic Acid
Dosage form: CAPSULE
Route: ORAL
Labeler: Manchester Pharmaceuticals, LLC
Application: NDA205750
Marketing category: NDA
Marketing start: 2015-03-31
Marketing end: 0000-00-00
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: 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	45043-001	45043-001-02	D	Discontinued by firm		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 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
2026-02-19 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…`
2021-12-28 21:50 UTC	2021-12	N205750-001	CHOLBAM	50MG	CAPSULE / ORAL	RLD	2015-03-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N205750-002	CHOLBAM	250MG	CAPSULE / ORAL	RLD, RS	2015-03-17	`782e0a99824c…`

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…`

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45043-001-02	EA - Each	45043-001	1676d751-f3af-4862-92fb-26faf1b5817a	1	2015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Cholic Acid	ACTIVE INGREDIENT	G1JO7801AE	CHOLBAM (CHOLIC ACID) CAPSULE [MANCHESTER PHARMACEUTICALS]	1
Cholic Acid	ACTIVE MOIETY	G1JO7801AE	CHOLBAM (CHOLIC ACID) CAPSULE [MANCHESTER PHARMACEUTICALS]	1
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CHOLBAM (CHOLIC ACID) CAPSULE [MANCHESTER PHARMACEUTICALS]	1
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CHOLBAM (CHOLIC ACID) CAPSULE [MANCHESTER PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45043-001	CHOLBAM (CHOLIC ACID) CAPSULE [MANCHESTER PHARMACEUTICALS, LLC]	9	Legacy NDC	20230404_e5b67402-8550-4604-97a0-c7b149fbf753.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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45043-001-02	45043000102	90 CAPSULE in 1 BOTTLE (45043-001-02)	90 capsule	2015-03-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cholbam	Manchester Pharmaceuticals, LLC \| Travere Therapeutics, Inc \| Patheon France S.A.S	2025-12-12	HUMAN PRESCRIPTION DRUG LABEL	10