opdivo

Generic: nivolumab

Labeler: e.r. squibb & sons, l.l.c.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name opdivo
Generic Name nivolumab
Labeler e.r. squibb & sons, l.l.c.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

nivolumab 10 mg/mL

Manufacturer
E.R. Squibb & Sons, L.L.C.

Identifiers & Regulatory

Product NDC 0003-3772
Product ID 0003-3772_7cacf42a-76d0-48de-9f0e-02b6912a6641
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125554
Listing Expiration 2026-12-31
Marketing Start 2014-12-22

Pharmacologic Class

Established (EPC)
programmed death receptor-1 blocking antibody [epc]
Mechanism of Action
programmed death receptor-1-directed antibody interactions [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00033772
Hyphenated Format 0003-3772

Supplemental Identifiers

RxCUI
1657190 1657192 1657195 1657196 1991412 1991413 2569080 2569081
UNII
31YO63LBSN
NUI
N0000191260 N0000191259

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name opdivo (source: ndc)
Generic Name nivolumab (source: ndc)
Application Number BLA125554 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0003-3772-11) / 4 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0003-3772-11 1 VIAL, SINGLE-DOSE in 1 CARTON (0003-3772-11) / 4 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

nivolumab (10 mg/mL)

Linked Drug Pages (1)

OPDIVO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "7cacf42a-76d0-48de-9f0e-02b6912a6641", "openfda": {"nui": ["N0000191260", "N0000191259"], "unii": ["31YO63LBSN"], "rxcui": ["1657190", "1657192", "1657195", "1657196", "1991412", "1991413", "2569080", "2569081"], "spl_set_id": ["f570b9c4-6846-4de2-abfa-4d0a4ae4e394"], "pharm_class_epc": ["Programmed Death Receptor-1 Blocking Antibody [EPC]"], "pharm_class_moa": ["Programmed Death Receptor-1-directed Antibody Interactions [MoA]"], "manufacturer_name": ["E.R. Squibb & Sons, L.L.C."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0003-3772-11)  / 4 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0003-3772-11", "marketing_start_date": "20141222"}], "brand_name": "OPDIVO", "product_id": "0003-3772_7cacf42a-76d0-48de-9f0e-02b6912a6641", "dosage_form": "INJECTION", "pharm_class": ["Programmed Death Receptor-1 Blocking Antibody [EPC]", "Programmed Death Receptor-1-directed Antibody Interactions [MoA]"], "product_ndc": "0003-3772", "generic_name": "nivolumab", "labeler_name": "E.R. Squibb & Sons, L.L.C.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OPDIVO", "active_ingredients": [{"name": "NIVOLUMAB", "strength": "10 mg/mL"}], "application_number": "BLA125554", "marketing_category": "BLA", "marketing_start_date": "20141222", "listing_expiration_date": "20261231"}