FDA.reportPublic FDA data

Livmarli

Product NDC
79378-110
11-digit product format
793780110
Labeler code
79378
Product ID
79378-110_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
2021-09-29
Substance
MARALIXIBAT CHLORIDE
Active strength
9.5 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MARALIXIBAT CHLORIDE9.5 mg/mL

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
79378-110-01Livmarli30 mL in 1 BOTTLESOLUTION3011
79378-110-01Livmarli1 in 1 CARTONSOLUTION111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
79378-110-01ML - Milliliter79378-110089a615e-d6e6-42ca-bdad-68ef2f9b1def12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79378-110LIVMARLI (MARALIXIBAT CHLORIDE) SOLUTION LIVMARLI (MARALIXIBAT CHLORIDE) TABLET [MIRUM PHARMACEUTICALS INC.]11Current NDC, Legacy 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 startMarketing endSampleExclude flagStatus
79378-110-01793780110011 BOTTLE in 1 CARTON (79378-110-01) / 30 mL in 1 BOTTLE1 bottle2021-09-290000-00-00NoNoCurrent