FDA.reportPublic FDA data

LEROCHOL

Product NDC
84685-300
11-digit product format
846850300
Labeler code
84685
Product ID
84685-300_593f8f9d-235b-4753-8843-4d7e6d6d5365
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lerodalcibep-liga
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
LIB Therapeutics, Inc.
Application
BLA761427
Marketing category
BLA
Marketing start
2025-12-15
Substance
LERODALCIBEP
Active strength
300 mg/1.2mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LERODALCIBEP300 mg/1.2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1PHP3QG5PZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2729467Internal RxNorm lookup
2729474Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
422f8b04-6ce8-4e64-a0a9-0ccc9a4a5860Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84685-300-01LEROCHOL1 in 1 CARTONINJECTION, SOLUTION12
84685-300-01LEROCHOL1.2 mL in 1 SYRINGEINJECTION, SOLUTION1.22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84685-300-01ML - Milliliter84685-30074103817-3ce8-48b9-9551-fdcbdbdacaa612026-04-20

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LEROCHOLLERODALCIBEP-LIGALIB Therapeutics, Inc.422f8b04-6ce8-4e64-a0a9-0ccc9a4a58602026-07-28Adverse reactionsExact identifier
application number: BLA761427
ndc (product): 84685-300

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761427Lerochollerodalcibep-liga351(a)Rx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2729474LEROCHOL 300 MG in 1.2 ML Prefilled SyringePSN422f8b04-6ce8-4e64-a0a9-0ccc9a4a58602
2729467lerodalcibep-liga 300 MG in 1.2 ML Prefilled SyringePSN422f8b04-6ce8-4e64-a0a9-0ccc9a4a58602
27294741.2 ML lerodalcibep-liga 250 MG/ML Prefilled Syringe [Lerochol]SBD422f8b04-6ce8-4e64-a0a9-0ccc9a4a58602
27294671.2 ML lerodalcibep-liga 250 MG/ML Prefilled SyringeSCD422f8b04-6ce8-4e64-a0a9-0ccc9a4a58602
2729474Lerochol 250 MG/ML per 1.2 ML Prefilled SyringeSY422f8b04-6ce8-4e64-a0a9-0ccc9a4a58602
2729474Lerochol 300 MG per 1.2 ML Prefilled SyringeSY422f8b04-6ce8-4e64-a0a9-0ccc9a4a58602
2729467lerodalcibep-liga 250 MG/ML per 1.2 ML Prefilled SyringeSY422f8b04-6ce8-4e64-a0a9-0ccc9a4a58602
2729467lerodalcibep-liga 300 MG per 1.2 ML Prefilled SyringeSY422f8b04-6ce8-4e64-a0a9-0ccc9a4a58602

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84685-300-01846850300011 SYRINGE in 1 CARTON (84685-300-01) / 1.2 mL in 1 SYRINGE1 syringe2026-03-31NoNoCurrent