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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LERODALCIBEP300 mg/1.2mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1PHP3QG5PZ
Rxcui2729467, 2729474

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

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 syringe2026-03-31NoNoHistorical