FDA.reportPublic FDA data

ERBITUX

Product NDC
66733-958
11-digit product format
667330958
Labeler code
66733
Product ID
66733-958_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
2007-10-02
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 Identifiers#

Field, Values table
FieldValues
UniiPQX0D8J21J
Rxcui1657658, 1657660, 1657663, 1657664

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
66733-958-232024-01-30C16284748780-11030e365-37c2-111a-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
66733-958-23ERBITUX1 in 1 CARTONSOLUTION158
66733-958-23ERBITUX100 mL in 1 VIAL, SINGLE-DOSESOLUTION10058

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66733-958-23ML - Milliliter66733-958d789986e-b9cf-47d4-a011-ea7bbe52c74112012-07-24

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
66733-958ERBITUX (CETUXIMAB) SOLUTION [IMCLONE LLC]57Current NDC, Legacy NDC, 2 package rows20240727_8bc6397e-4bd8-4d37-a007-a327e4da34d9.zip

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
66733-958-23667330958231 VIAL, SINGLE-DOSE in 1 CARTON (66733-958-23) / 100 mL in 1 VIAL, SINGLE-DOSE2007-10-020000-00-00NoNoCurrent