Livmarli

Product NDC: 79378-111
11-digit product format: 793780111
Labeler code: 79378
Product ID: 79378-111_560d193b-5be5-4799-adfc-f7b36dddd434
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: maralixibat chloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Mirum Pharmaceuticals Inc.
Application: NDA214662
Marketing category: NDA
Marketing start: 2024-07-24
Substance: MARALIXIBAT CHLORIDE
Active strength: 19 mg/mL
Pharmacologic classes: Ileal Bile Acid Transporter Inhibitor [EPC], Ileal Bile Acid Transporter Inhibitors [MoA], Organic Anion Transporting Polypeptide 2B1 Inhibitors [MoA]
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 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
N214662-001	LIVMARLI	MARALIXIBAT CHLORIDE	EQ 9.5MG BASE/ML	SOLUTION / ORAL		RLD, RS	2021-09-29
N214662-002	LIVMARLI	MARALIXIBAT CHLORIDE	EQ 19MG BASE/ML	SOLUTION / ORAL		RLD, RS	2024-07-24

Orange Book patents#

Current patent rows page 1 of 1 · 17 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N214662-001	11260053	2031-05-26	U-3290	2022-03-01
N214662-001	11260053	2031-05-26	U-3974	2022-03-01
N214662-001	10512657	2032-10-26	U-3850	2024-03-22
N214662-001	11229661	2032-10-26	U-3850	2024-03-22
N214662-001	11376251	2032-10-26	U-3290	2022-07-19
N214662-001	11376251	2032-10-26	U-3974	2022-07-19
N214662-001	11229647	2040-02-12	U-3290	2022-02-01
N214662-001	11229647	2040-02-12	U-3974	2022-02-01
N214662-001	11497745	2040-02-12	U-3290	2022-11-30
N214662-001	11497745	2040-02-12	U-3974	2022-11-30
N214662-001	11918578	2040-02-12	U-3290	2024-03-22
N214662-001	11918578	2040-02-12	U-3974	2024-03-22
N214662-001	12599602	2040-02-12	U-3290	2026-04-22
N214662-001	12599602	2040-02-12	U-3974	2026-04-22
N214662-002	10512657	2032-10-26	U-3973	2024-08-23
N214662-002	11229661	2032-10-26	U-3973	2024-08-23
N214662-002	12350267	2032-10-26	U-3973	2025-08-05

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 11 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214662-001	NPP	2026-03-13
N214662-001	NCE	2026-09-29
N214662-001	I-938	2027-03-13
N214662-001	ODE-379	2028-09-29
N214662-001	ODE-429	2030-03-13
N214662-001	ODE-471	2031-03-13
N214662-002	NCE	2026-09-29
N214662-002	ODE*	2028-09-29
N214662-002	ODE*	2030-03-13
N214662-002	ODE*	2031-03-13
N214662-002	ODE-490	2031-07-24

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N214662-001	LIVMARLI	EQ 9.5MG BASE/ML	SOLUTION / ORAL		RLD, RS	2021-09-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214662-002	LIVMARLI	EQ 19MG BASE/ML	SOLUTION / ORAL		RLD, RS	2024-07-24	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N214662-001	11260053	2031-05-26	U-3974	2022-03-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214662-001	11260053	2031-05-26	U-3290	2022-03-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214662-001	10512657	2032-10-26	U-3850	2024-03-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214662-001	11229661	2032-10-26	U-3850	2024-03-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214662-001	11376251	2032-10-26	U-3290	2022-07-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214662-001	11376251	2032-10-26	U-3974	2022-07-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214662-001	11229647	2040-02-12	U-3974	2022-02-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214662-001	11229647	2040-02-12	U-3290	2022-02-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214662-001	11497745	2040-02-12	U-3974	2022-11-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214662-001	11497745	2040-02-12	U-3290	2022-11-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214662-001	11918578	2040-02-12	U-3290	2024-03-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214662-001	11918578	2040-02-12	U-3974	2024-03-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214662-001	12599602	2040-02-12	U-3974	2026-04-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214662-001	12599602	2040-02-12	U-3290	2026-04-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214662-002	10512657	2032-10-26	U-3973	2024-08-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214662-002	11229661	2032-10-26	U-3973	2024-08-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214662-002	12350267	2032-10-26	U-3973	2025-08-05	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-01 22:54:32	2026-06	N214662-001	NPP	2026-03-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214662-001	NCE	2026-09-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214662-001	I-938	2027-03-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214662-001	ODE-379	2028-09-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214662-001	ODE-429	2030-03-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214662-001	ODE-471	2031-03-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214662-002	NCE	2026-09-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214662-002	ODE*	2028-09-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214662-002	ODE*	2030-03-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214662-002	ODE*	2031-03-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214662-002	ODE-490	2031-07-24	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
Livmarli	MARALIXIBAT CHLORIDE	Mirum Pharmaceuticals Inc.	64000394-1ef6-4e76-8ba8-11f25ba1b167	2025-04-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214662 application number: NDA214662 ndc (product): 79378-111

Additional Listing Data#

Finished product: Yes
Brand name base: Livmarli
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MARALIXIBAT CHLORIDE	19 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V78M04F0XC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2571079	Internal RxNorm lookup
2571085	Internal RxNorm lookup
2690990	Internal RxNorm lookup
2690992	Internal RxNorm lookup
2712463	Internal RxNorm lookup
2712467	Internal RxNorm lookup
2712469	Internal RxNorm lookup
2712471	Internal RxNorm lookup
2712473	Internal RxNorm lookup
2712475	Internal RxNorm lookup
2712477	Internal RxNorm lookup
2712479	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
64000394-1ef6-4e76-8ba8-11f25ba1b167	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
848afaf6-6fc2-42e9-8f69-b079c49dfd98	Product name	2	20260126

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
79378-111-01	Livmarli	30 mL in 1 BOTTLE	SOLUTION	30		11
79378-111-01	Livmarli	1 in 1 CARTON	SOLUTION	1		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
79378-111-01	ML - Milliliter	79378-111	5f71fbdd-25af-41ec-9fd2-8f5d900f09b0	1	2024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79378-111	LIVMARLI (MARALIXIBAT CHLORIDE) SOLUTION LIVMARLI (MARALIXIBAT CHLORIDE) TABLET [MIRUM PHARMACEUTICALS INC.]	11	Current NDC, 2 package rows	20250426_64000394-1ef6-4e76-8ba8-11f25ba1b167.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V78M04F0XC	MARALIXIBAT CHLORIDE	228113-66-4	MARALIXIBAT CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2712467	Livmarli 10 MG Oral Tablet	PSN	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2712479	Livmarli 15 MG Oral Tablet	PSN	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2690992	Livmarli 19 MG/mL Oral Solution	PSN	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2712471	Livmarli 20 MG Oral Tablet	PSN	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2712475	Livmarli 30 MG Oral Tablet	PSN	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2571085	Livmarli 9.5 MG/mL Oral Solution	PSN	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2712463	maralixibat 10 MG Oral Tablet	PSN	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2712477	maralixibat 15 MG Oral Tablet	PSN	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2690990	maralixibat 19 MG/mL Oral Solution	PSN	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2712469	maralixibat 20 MG Oral Tablet	PSN	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2712473	maralixibat 30 MG Oral Tablet	PSN	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2571079	maralixibat 9.5 MG/mL Oral Solution	PSN	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2712467	maralixibat 10 MG Oral Tablet [Livmarli]	SBD	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2712479	maralixibat 15 MG Oral Tablet [Livmarli]	SBD	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2690992	maralixibat 19 MG/ML Oral Solution [Livmarli]	SBD	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2712471	maralixibat 20 MG Oral Tablet [Livmarli]	SBD	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2712475	maralixibat 30 MG Oral Tablet [Livmarli]	SBD	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2571085	maralixibat 9.5 MG/ML Oral Solution [Livmarli]	SBD	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2712463	maralixibat 10 MG Oral Tablet	SCD	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2712477	maralixibat 15 MG Oral Tablet	SCD	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2690990	maralixibat 19 MG/ML Oral Solution	SCD	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2712469	maralixibat 20 MG Oral Tablet	SCD	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2712473	maralixibat 30 MG Oral Tablet	SCD	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2571079	maralixibat 9.5 MG/ML Oral Solution	SCD	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2712463	10 MG (equivalent to maralixibat chloride 10.5 MG) Oral Tablet	SY	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2571085	Livmarli (as maralixibat chloride 10 MG/ML) 9.5 MG/ML Oral Solution	SY	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2712467	Livmarli 10 MG (equivalent to maralixibat chloride 10.5 MG) Oral Tablet	SY	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2712467	Livmarli 10 MG Oral Tablet	SY	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2712479	Livmarli 15 MG (equivalent to maralixibat chloride 15.8 MG) Oral Tablet	SY	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2712479	Livmarli 15 MG Oral Tablet	SY	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2690992	Livmarli 19 MG/ML Oral Solution	SY	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2712471	Livmarli 20 MG (equivalent to maralixibat chloride 21 MG) Oral Tablet	SY	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2712471	Livmarli 20 MG Oral Tablet	SY	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2712475	Livmarli 30 MG (equivalent to maralixibat chloride 31.6 MG) Oral Tablet	SY	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2712475	Livmarli 30 MG Oral Tablet	SY	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2571079	maralixibat (as maralixibat chloride 10 MG/ML) 9.5 MG/ML Oral Solution	SY	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2712477	maralixibat 15 MG (equivalent to maralixibat chloride 15.8 MG) Oral Tablet	SY	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2690990	maralixibat 19 MG/mL (as maralixibat chloride 20 MG/mL) Oral Solution	SY	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2712469	maralixibat 20 MG (equivalent to maralixibat chloride 21 MG) Oral Tablet	SY	64000394-1ef6-4e76-8ba8-11f25ba1b167	11
2712473	maralixibat 30 MG (equivalent to maralixibat chloride 31.6 MG) Oral Tablet	SY	64000394-1ef6-4e76-8ba8-11f25ba1b167	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
79378-111-01	79378011101	1 BOTTLE in 1 CARTON (79378-111-01) / 30 mL in 1 BOTTLE	1 bottle	2024-07-24	No	No	Current