FDA.reportPublic FDA data

ERBITUX

Product NDC
66733-948
11-digit product format
667330948
Labeler code
66733
Product ID
66733-948_1cd448bd-5230-450c-ad4c-359e6d54cd2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cetuximab
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
ImClone LLC
Application
BLA125084
Marketing category
BLA
Marketing start
2004-02-12
Substance
CETUXIMAB
Active strength
2 mg/mL
Pharmacologic classes
Epidermal Growth Factor Receptor Antagonist [EPC], HER1 Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETUXIMAB2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PQX0D8J21JInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1657658Internal RxNorm lookup
1657660Internal RxNorm lookup
1657663Internal RxNorm lookup
1657664Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8bc6397e-4bd8-4d37-a007-a327e4da34d9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
0ff2bd88-bce9-4180-bdbf-b57a23b84f5fProduct name120161206
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66733-948-232024-01-30C16284748780-11030e365-37c2-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ERBITUX safely and effectively. See full prescribing information for ERBITUX. ERBITUX ® (cetuximab) injection, for intravenous use Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66733-948-23ERBITUX50 mL in 1 VIAL, SINGLE-DOSESOLUTION5058
66733-948-23ERBITUX1 in 1 CARTONSOLUTION158

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66733-948-23ML - Milliliter66733-948c3dbba5c-336b-4ddb-9b90-ba481d62a52a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
cetuximabACTIVE INGREDIENTPQX0D8J21JERBITUX (CETUXIMAB) SOLUTION [IMCLONE LLC]34
cetuximabACTIVE MOIETYPQX0D8J21JERBITUX (CETUXIMAB) SOLUTION [IMCLONE LLC]34
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XERBITUX (CETUXIMAB) SOLUTION [IMCLONE LLC]34
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEINACTIVE INGREDIENT70WT22SF4BERBITUX (CETUXIMAB) SOLUTION [IMCLONE LLC]34
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNERBITUX (CETUXIMAB) SOLUTION [IMCLONE LLC]34
WATERINACTIVE INGREDIENT059QF0KO0RERBITUX (CETUXIMAB) SOLUTION [IMCLONE LLC]34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66733-948ERBITUX (CETUXIMAB) SOLUTION [IMCLONE LLC]57Current NDC, Legacy NDC, 2 package rows20240727_8bc6397e-4bd8-4d37-a007-a327e4da34d9.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
ERBITUXCETUXIMABImClone LLC8bc6397e-4bd8-4d37-a007-a327e4da34d92026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125084
ndc (product): 66733-948

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125084Erbituxcetuximab351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1657658cetuximab 100 MG in 50 ML InjectionPSN8bc6397e-4bd8-4d37-a007-a327e4da34d958
1657663cetuximab 200 MG in 100 ML InjectionPSN8bc6397e-4bd8-4d37-a007-a327e4da34d958
1657660Erbitux 100 MG in 50 ML InjectionPSN8bc6397e-4bd8-4d37-a007-a327e4da34d958
1657664Erbitux 200 MG in 100 ML InjectionPSN8bc6397e-4bd8-4d37-a007-a327e4da34d958
1657664100 ML cetuximab 2 MG/ML Injection [Erbitux]SBD8bc6397e-4bd8-4d37-a007-a327e4da34d958
165766050 ML cetuximab 2 MG/ML Injection [Erbitux]SBD8bc6397e-4bd8-4d37-a007-a327e4da34d958
1657663100 ML cetuximab 2 MG/ML InjectionSCD8bc6397e-4bd8-4d37-a007-a327e4da34d958
165765850 ML cetuximab 2 MG/ML InjectionSCD8bc6397e-4bd8-4d37-a007-a327e4da34d958
1657658cetuximab 100 MG per 50 ML InjectionSY8bc6397e-4bd8-4d37-a007-a327e4da34d958
1657663cetuximab 200 MG per 100 ML InjectionSY8bc6397e-4bd8-4d37-a007-a327e4da34d958
1657660Erbitux 100 MG per 50 ML InjectionSY8bc6397e-4bd8-4d37-a007-a327e4da34d958
1657664Erbitux 200 MG per 100 ML InjectionSY8bc6397e-4bd8-4d37-a007-a327e4da34d958

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66733-948-23667330948231 VIAL, SINGLE-DOSE in 1 CARTON (66733-948-23) / 50 mL in 1 VIAL, SINGLE-DOSE2004-02-120000-00-00NoNoCurrent