FDA.reportPublic FDA data

Livmarli

Product NDC
79378-230
11-digit product format
793780230
Labeler code
79378
Product ID
79378-230_560d193b-5be5-4799-adfc-f7b36dddd434
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
maralixibat chloride
Dosage form
TABLET
Route
ORAL
Labeler
Mirum Pharmaceuticals Inc.
Application
NDA219485
Marketing category
NDA
Marketing start
2025-04-10
Substance
MARALIXIBAT CHLORIDE
Active strength
30 mg/1
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MARALIXIBAT CHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV78M04F0XC
Rxcui2571079, 2571085, 2690990, 2690992, 2712463, 2712467, 2712469, 2712471, 2712473, 2712475, 2712477, 2712479

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
848afaf6-6fc2-42e9-8f69-b079c49dfd98Product name220260126

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79378-230-30Livmarli30 in 1 BOTTLETABLET3011
79378-230-30Livmarli1 in 1 CARTONTABLET111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
79378-230-30EA - Each79378-2305716cc60-c2a5-44ed-9cf0-963e825ba38c12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79378-230LIVMARLI (MARALIXIBAT CHLORIDE) SOLUTION LIVMARLI (MARALIXIBAT CHLORIDE) TABLET [MIRUM PHARMACEUTICALS INC.]11Current NDC, 2 package rows20250426_64000394-1ef6-4e76-8ba8-11f25ba1b167.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2712467Livmarli 10 MG Oral TabletPSN64000394-1ef6-4e76-8ba8-11f25ba1b16711
2712479Livmarli 15 MG Oral TabletPSN64000394-1ef6-4e76-8ba8-11f25ba1b16711
2690992Livmarli 19 MG/mL Oral SolutionPSN64000394-1ef6-4e76-8ba8-11f25ba1b16711
2712471Livmarli 20 MG Oral TabletPSN64000394-1ef6-4e76-8ba8-11f25ba1b16711
2712475Livmarli 30 MG Oral TabletPSN64000394-1ef6-4e76-8ba8-11f25ba1b16711
2571085Livmarli 9.5 MG/mL Oral SolutionPSN64000394-1ef6-4e76-8ba8-11f25ba1b16711
2712463maralixibat 10 MG Oral TabletPSN64000394-1ef6-4e76-8ba8-11f25ba1b16711
2712477maralixibat 15 MG Oral TabletPSN64000394-1ef6-4e76-8ba8-11f25ba1b16711
2690990maralixibat 19 MG/mL Oral SolutionPSN64000394-1ef6-4e76-8ba8-11f25ba1b16711
2712469maralixibat 20 MG Oral TabletPSN64000394-1ef6-4e76-8ba8-11f25ba1b16711
2712473maralixibat 30 MG Oral TabletPSN64000394-1ef6-4e76-8ba8-11f25ba1b16711
2571079maralixibat 9.5 MG/mL Oral SolutionPSN64000394-1ef6-4e76-8ba8-11f25ba1b16711
2712467maralixibat 10 MG Oral Tablet [Livmarli]SBD64000394-1ef6-4e76-8ba8-11f25ba1b16711
2712479maralixibat 15 MG Oral Tablet [Livmarli]SBD64000394-1ef6-4e76-8ba8-11f25ba1b16711
2690992maralixibat 19 MG/ML Oral Solution [Livmarli]SBD64000394-1ef6-4e76-8ba8-11f25ba1b16711
2712471maralixibat 20 MG Oral Tablet [Livmarli]SBD64000394-1ef6-4e76-8ba8-11f25ba1b16711
2712475maralixibat 30 MG Oral Tablet [Livmarli]SBD64000394-1ef6-4e76-8ba8-11f25ba1b16711
2571085maralixibat 9.5 MG/ML Oral Solution [Livmarli]SBD64000394-1ef6-4e76-8ba8-11f25ba1b16711
2712463maralixibat 10 MG Oral TabletSCD64000394-1ef6-4e76-8ba8-11f25ba1b16711
2712477maralixibat 15 MG Oral TabletSCD64000394-1ef6-4e76-8ba8-11f25ba1b16711
2690990maralixibat 19 MG/ML Oral SolutionSCD64000394-1ef6-4e76-8ba8-11f25ba1b16711
2712469maralixibat 20 MG Oral TabletSCD64000394-1ef6-4e76-8ba8-11f25ba1b16711
2712473maralixibat 30 MG Oral TabletSCD64000394-1ef6-4e76-8ba8-11f25ba1b16711
2571079maralixibat 9.5 MG/ML Oral SolutionSCD64000394-1ef6-4e76-8ba8-11f25ba1b16711
271246310 MG (equivalent to maralixibat chloride 10.5 MG) Oral TabletSY64000394-1ef6-4e76-8ba8-11f25ba1b16711
2571085Livmarli (as maralixibat chloride 10 MG/ML) 9.5 MG/ML Oral SolutionSY64000394-1ef6-4e76-8ba8-11f25ba1b16711
2712467Livmarli 10 MG (equivalent to maralixibat chloride 10.5 MG) Oral TabletSY64000394-1ef6-4e76-8ba8-11f25ba1b16711
2712467Livmarli 10 MG Oral TabletSY64000394-1ef6-4e76-8ba8-11f25ba1b16711
2712479Livmarli 15 MG (equivalent to maralixibat chloride 15.8 MG) Oral TabletSY64000394-1ef6-4e76-8ba8-11f25ba1b16711
2712479Livmarli 15 MG Oral TabletSY64000394-1ef6-4e76-8ba8-11f25ba1b16711
2690992Livmarli 19 MG/ML Oral SolutionSY64000394-1ef6-4e76-8ba8-11f25ba1b16711
2712471Livmarli 20 MG (equivalent to maralixibat chloride 21 MG) Oral TabletSY64000394-1ef6-4e76-8ba8-11f25ba1b16711
2712471Livmarli 20 MG Oral TabletSY64000394-1ef6-4e76-8ba8-11f25ba1b16711
2712475Livmarli 30 MG (equivalent to maralixibat chloride 31.6 MG) Oral TabletSY64000394-1ef6-4e76-8ba8-11f25ba1b16711
2712475Livmarli 30 MG Oral TabletSY64000394-1ef6-4e76-8ba8-11f25ba1b16711
2571079maralixibat (as maralixibat chloride 10 MG/ML) 9.5 MG/ML Oral SolutionSY64000394-1ef6-4e76-8ba8-11f25ba1b16711
2712477maralixibat 15 MG (equivalent to maralixibat chloride 15.8 MG) Oral TabletSY64000394-1ef6-4e76-8ba8-11f25ba1b16711
2690990maralixibat 19 MG/mL (as maralixibat chloride 20 MG/mL) Oral SolutionSY64000394-1ef6-4e76-8ba8-11f25ba1b16711
2712469maralixibat 20 MG (equivalent to maralixibat chloride 21 MG) Oral TabletSY64000394-1ef6-4e76-8ba8-11f25ba1b16711
2712473maralixibat 30 MG (equivalent to maralixibat chloride 31.6 MG) Oral TabletSY64000394-1ef6-4e76-8ba8-11f25ba1b16711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79378-230-30793780230301 BOTTLE in 1 CARTON (79378-230-30) / 30 TABLET in 1 BOTTLE1 bottle2025-04-10NoNoCurrent