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 Identifiers#

Field, Values table
FieldValues
Unii6A901E312A
Rxcui1657703, 1657705, 1657722, 1657723

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

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