FDA.reportPublic FDA data

LIBTAYO

Product NDC
61755-008
11-digit product format
617550008
Labeler code
61755
Product ID
61755-008_541a4e20-6a70-4164-8504-413f0d654042
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cemiplimab-rwlc
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Regeneron Pharmaceuticals, Inc.
Application
BLA761097
Marketing category
BLA
Marketing start
2018-09-28
Substance
CEMIPLIMAB
Active strength
50 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEMIPLIMAB50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6QVL057INTInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2058830Internal RxNorm lookup
2058835Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4347ae1f-d397-4f18-8b70-03897e1c054aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d0e6285b-2665-4e87-b837-4c1da83e8282Product name120190114
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61755-008-01LIBTAYO7 mL in 1 VIAL, SINGLE-USEINJECTION723
61755-008-01LIBTAYO1 in 1 CARTONINJECTION123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61755-008-01ML - Milliliter61755-008dab99865-33c5-4546-b4dd-89ebd973df9212018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61755-008LIBTAYO (CEMIPLIMAB-RWLC) INJECTION [REGENERON PHARMACEUTICALS, INC.]20Current NDC, Legacy NDC, 2 package rows20240608_4347ae1f-d397-4f18-8b70-03897e1c054a.zip

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
LIBTAYOCEMIPLIMAB-RWLCRegeneron Pharmaceuticals, Inc.4347ae1f-d397-4f18-8b70-03897e1c054a2025-10-29Warnings, Adverse reactionsExact identifier
application number: BLA761097
ndc (product): 61755-008

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761097Libtayocemiplimab-rwlc351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2058830cemiplimab-rwlc 350 MG in 7 ML InjectionPSN4347ae1f-d397-4f18-8b70-03897e1c054a23
2058835LIBTAYO 350 MG in 7 ML InjectionPSN4347ae1f-d397-4f18-8b70-03897e1c054a23
20588357 ML cemiplimab-rwlc 50 MG/ML Injection [Libtayo]SBD4347ae1f-d397-4f18-8b70-03897e1c054a23
20588307 ML cemiplimab-rwlc 50 MG/ML InjectionSCD4347ae1f-d397-4f18-8b70-03897e1c054a23
2058830cemiplimab-rwlc 350 MG per 7 ML InjectionSY4347ae1f-d397-4f18-8b70-03897e1c054a23
2058830cemiplimab-rwlc 50 MG/ML per 7 ML InjectionSY4347ae1f-d397-4f18-8b70-03897e1c054a23
2058835Libtayo 350 MG per 7 ML InjectionSY4347ae1f-d397-4f18-8b70-03897e1c054a23
2058835Libtayo 50 MG/ML per 7 ML InjectionSY4347ae1f-d397-4f18-8b70-03897e1c054a23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61755-008-01617550008011 VIAL, SINGLE-USE in 1 CARTON (61755-008-01) / 7 mL in 1 VIAL, SINGLE-USE2018-09-280000-00-00NoNoCurrent