FDA.reportPublic FDA data

OPDIVO

Product NDC
0003-3756
11-digit product format
000033756
Labeler code
0003
Product ID
0003-3756_645d02cf-536a-4ceb-b812-660735b38e92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nivolumab
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
E.R. Squibb & Sons, L.L.C.
Application
BLA125554
Marketing category
BLA
Marketing start
2021-08-30
Substance
NIVOLUMAB
Active strength
10 mg/mL
Pharmacologic classes
Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NIVOLUMAB10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
31YO63LBSNInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1657190Internal RxNorm lookup
1657192Internal RxNorm lookup
1657195Internal RxNorm lookup
1657196Internal RxNorm lookup
1991412Internal RxNorm lookup
1991413Internal RxNorm lookup
2569080Internal RxNorm lookup
2569081Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f570b9c4-6846-4de2-abfa-4d0a4ae4e394Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
64196b0b-840e-435b-8afa-0b0e9d9cea99Product name120251024
cc8aeb65-d09e-4803-a7f6-91602fc46900Product name120230103
d9ed9875-2de0-480e-b03d-305aab8310a6Product name220160211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0003-3756-14OPDIVO1 in 1 CARTONINJECTION167
0003-3756-14OPDIVO12 mL in 1 VIAL, SINGLE-DOSEINJECTION1267

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0003-3756-14ML - Milliliter0003-37565eb331a7-ff6d-48fe-85b5-e5be6b2f630d12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0003-3756OPDIVO (NIVOLUMAB) INJECTION [E.R. SQUIBB & SONS, L.L.C.]61Current NDC, Legacy NDC, 2 package rows20250426_f570b9c4-6846-4de2-abfa-4d0a4ae4e394.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
OPDIVONIVOLUMABE.R. Squibb & Sons, L.L.C.f570b9c4-6846-4de2-abfa-4d0a4ae4e3942026-05-12Warnings, Adverse reactionsExact identifier
application number: BLA125554
ndc (product): 0003-3756

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125554Opdivonivolumab351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1657195nivolumab 100 MG in 10 ML InjectionPSNf570b9c4-6846-4de2-abfa-4d0a4ae4e39467
2569080nivolumab 120 MG in 12 ML InjectionPSNf570b9c4-6846-4de2-abfa-4d0a4ae4e39467
1991412nivolumab 240 MG in 24 ML InjectionPSNf570b9c4-6846-4de2-abfa-4d0a4ae4e39467
1657190nivolumab 40 MG in 4 ML InjectionPSNf570b9c4-6846-4de2-abfa-4d0a4ae4e39467
1657196Opdivo 100 MG in 10 ML InjectionPSNf570b9c4-6846-4de2-abfa-4d0a4ae4e39467
2569081Opdivo 120 MG in 12 ML InjectionPSNf570b9c4-6846-4de2-abfa-4d0a4ae4e39467
1991413Opdivo 240 MG in 24 ML InjectionPSNf570b9c4-6846-4de2-abfa-4d0a4ae4e39467
1657192Opdivo 40 MG in 4 ML InjectionPSNf570b9c4-6846-4de2-abfa-4d0a4ae4e39467
165719610 ML nivolumab 10 MG/ML Injection [Opdivo]SBDf570b9c4-6846-4de2-abfa-4d0a4ae4e39467
256908112 ML nivolumab 10 MG/ML Injection [Opdivo]SBDf570b9c4-6846-4de2-abfa-4d0a4ae4e39467
199141324 ML nivolumab 10 MG/ML Injection [Opdivo]SBDf570b9c4-6846-4de2-abfa-4d0a4ae4e39467
16571924 ML nivolumab 10 MG/ML Injection [Opdivo]SBDf570b9c4-6846-4de2-abfa-4d0a4ae4e39467
165719510 ML nivolumab 10 MG/ML InjectionSCDf570b9c4-6846-4de2-abfa-4d0a4ae4e39467
256908012 ML nivolumab 10 MG/ML InjectionSCDf570b9c4-6846-4de2-abfa-4d0a4ae4e39467
199141224 ML nivolumab 10 MG/ML InjectionSCDf570b9c4-6846-4de2-abfa-4d0a4ae4e39467
16571904 ML nivolumab 10 MG/ML InjectionSCDf570b9c4-6846-4de2-abfa-4d0a4ae4e39467
256908112 ML Opdivo 10 MG/ML InjectionSYf570b9c4-6846-4de2-abfa-4d0a4ae4e39467
199141324 ML Opdivo 10 MG/ML InjectionSYf570b9c4-6846-4de2-abfa-4d0a4ae4e39467
1657195nivolumab 100 MG per 10 ML InjectionSYf570b9c4-6846-4de2-abfa-4d0a4ae4e39467
2569080nivolumab 120 MG per 12 ML InjectionSYf570b9c4-6846-4de2-abfa-4d0a4ae4e39467
1991412nivolumab 240 MG per 24 ML InjectionSYf570b9c4-6846-4de2-abfa-4d0a4ae4e39467
1657190nivolumab 40 MG per 4 ML InjectionSYf570b9c4-6846-4de2-abfa-4d0a4ae4e39467
1657196Opdivo 100 MG per 10 ML InjectionSYf570b9c4-6846-4de2-abfa-4d0a4ae4e39467
2569081Opdivo 120 MG per 12 ML InjectionSYf570b9c4-6846-4de2-abfa-4d0a4ae4e39467
1991413Opdivo 240 MG per 24 ML InjectionSYf570b9c4-6846-4de2-abfa-4d0a4ae4e39467
1657192Opdivo 40 MG per 4 ML InjectionSYf570b9c4-6846-4de2-abfa-4d0a4ae4e39467

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0003-3756-14000033756141 VIAL, SINGLE-DOSE in 1 CARTON (0003-3756-14) / 12 mL in 1 VIAL, SINGLE-DOSE2021-08-300000-00-00NoNoCurrent