FDA.reportPublic FDA data

Vectibix

Product NDC
55513-954
11-digit product format
555130954
Labeler code
55513
Product ID
55513-954_be266b46-ea99-47f5-b6c2-a2f8afc863c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
panitumumab
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Amgen, Inc
Application
BLA125147
Marketing category
BLA
Marketing start
2006-10-10
Substance
PANITUMUMAB
Active strength
100 mg/5mL
Pharmacologic classes
Antibodies, Monoclonal [CS], 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
Vectibix
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PANITUMUMAB100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6A901E312AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1657703Internal RxNorm lookup
1657705Internal RxNorm lookup
1657722Internal RxNorm lookup
1657723Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e0fa4bca-f245-4d92-ae29-b0c630a315c2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
0409a937-121d-48bc-b984-cac72526f82bProduct name120170810
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55513-954-01Vectibix1 in 1 CARTONSOLUTION1160
55513-954-01Vectibix5 mL in 1 VIAL, SINGLE-DOSESOLUTION5160
55513-954-21Vectibix5 mL in 1 VIAL, SINGLE-DOSESOLUTION5160
55513-954-21Vectibix1 in 1 CARTONSOLUTION1160

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-954-01ML - Milliliter55513-954f0b74d08-30c5-4e4f-aac4-3edf20ba236312013-02-13
55513-954-21ML - Milliliter55513-954b31f6519-edad-44c8-a2b6-c626594969e312026-02-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PANITUMUMABACTIVE INGREDIENT6A901E312AVECTIBIX (PANITUMUMAB) SOLUTION [AMGEN INC]147
PANITUMUMABACTIVE MOIETY6A901E312AVECTIBIX (PANITUMUMAB) SOLUTION [AMGEN INC]147
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BVECTIBIX (PANITUMUMAB) SOLUTION [AMGEN INC]147
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XVECTIBIX (PANITUMUMAB) SOLUTION [AMGEN INC]147
WATERINACTIVE INGREDIENT059QF0KO0RVECTIBIX (PANITUMUMAB) SOLUTION [AMGEN INC]147

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-954VECTIBIX (PANITUMUMAB) SOLUTION [AMGEN INC]158Current NDC, Legacy NDC, 4 package rows20250130_e0fa4bca-f245-4d92-ae29-b0c630a315c2.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
VectibixPANITUMUMABAmgen, Ince0fa4bca-f245-4d92-ae29-b0c630a315c22026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125147
ndc (product): 55513-954

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125147Vectibixpanitumumab351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1657703panitumumab 100 MG in 5 ML InjectionPSNe0fa4bca-f245-4d92-ae29-b0c630a315c2160
1657722panitumumab 400 MG in 20 ML InjectionPSNe0fa4bca-f245-4d92-ae29-b0c630a315c2160
1657705Vectibix 100 MG in 5 ML InjectionPSNe0fa4bca-f245-4d92-ae29-b0c630a315c2160
1657723Vectibix 400 MG in 20 ML InjectionPSNe0fa4bca-f245-4d92-ae29-b0c630a315c2160
165772320 ML panitumumab 20 MG/ML Injection [Vectibix]SBDe0fa4bca-f245-4d92-ae29-b0c630a315c2160
16577055 ML panitumumab 20 MG/ML Injection [Vectibix]SBDe0fa4bca-f245-4d92-ae29-b0c630a315c2160
165772220 ML panitumumab 20 MG/ML InjectionSCDe0fa4bca-f245-4d92-ae29-b0c630a315c2160
16577035 ML panitumumab 20 MG/ML InjectionSCDe0fa4bca-f245-4d92-ae29-b0c630a315c2160
1657703panitumumab 100 MG per 5 ML InjectionSYe0fa4bca-f245-4d92-ae29-b0c630a315c2160
1657722panitumumab 400 MG per 20 ML InjectionSYe0fa4bca-f245-4d92-ae29-b0c630a315c2160
1657705Vectibix 100 MG per 5 ML InjectionSYe0fa4bca-f245-4d92-ae29-b0c630a315c2160
1657723Vectibix 400 MG per 20 ML InjectionSYe0fa4bca-f245-4d92-ae29-b0c630a315c2160

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55513-954-01555130954011 VIAL, SINGLE-DOSE in 1 CARTON (55513-954-01) / 5 mL in 1 VIAL, SINGLE-DOSE2006-10-100000-00-00NoNoCurrent
55513-954-21555130954211 VIAL, SINGLE-DOSE in 1 CARTON (55513-954-21) / 5 mL in 1 VIAL, SINGLE-DOSE2025-10-01NoNoCurrent