Home NDC 0003-2328 YERVOY
Product NDC 0003-2328
11-digit product format 000032328
Labeler code 0003
Product ID 0003-2328_ecc3bf01-2632-4c2e-85aa-e34da43d25f2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ipilimumab
Dosage form INJECTION
Route INTRAVENOUS
Labeler E.R. Squibb & Sons, L.L.C.
Application BLA125377
Marketing category BLA
Marketing start 2011-03-25
Substance IPILIMUMAB
Active strength 5 mg/mL
Pharmacologic classes CTLA-4-directed Antibody Interactions [MoA], CTLA-4-directed Blocking Antibody [EPC], Increased T Lymphocyte Activation [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base YERVOY
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IPILIMUMAB 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6T8C155666 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1657005 Internal RxNorm lookup 1657007 Internal RxNorm lookup 1657012 Internal RxNorm lookup 1657013 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0003-2328-22 YERVOY 1 in 1 CARTON INJECTION 1 45 0003-2328-22 YERVOY 40 mL in 1 VIAL, SINGLE-USE INJECTION 40 45
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IPILIMUMAB ACTIVE INGREDIENT 6T8C155666 YERVOY (IPILIMUMAB) INJECTION [E.R. SQUIBB & SONS, L.L.C.] 12 IPILIMUMAB ACTIVE MOIETY 6T8C155666 YERVOY (IPILIMUMAB) INJECTION [E.R. SQUIBB & SONS, L.L.C.] 12 MANNITOL INACTIVE INGREDIENT 3OWL53L36A YERVOY (IPILIMUMAB) INJECTION [E.R. SQUIBB & SONS, L.L.C.] 12 PENTETIC ACID INACTIVE INGREDIENT 7A314HQM0I YERVOY (IPILIMUMAB) INJECTION [E.R. SQUIBB & SONS, L.L.C.] 12 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H YERVOY (IPILIMUMAB) INJECTION [E.R. SQUIBB & SONS, L.L.C.] 12 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X YERVOY (IPILIMUMAB) INJECTION [E.R. SQUIBB & SONS, L.L.C.] 12 TROMETHAMINE HYDROCHLORIDE INACTIVE INGREDIENT 383V75M34E YERVOY (IPILIMUMAB) INJECTION [E.R. SQUIBB & SONS, L.L.C.] 12 WATER INACTIVE INGREDIENT 059QF0KO0R YERVOY (IPILIMUMAB) INJECTION [E.R. SQUIBB & SONS, L.L.C.] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0003-2328 YERVOY (IPILIMUMAB) INJECTION [E.R. SQUIBB & SONS, L.L.C.] 44 Current NDC, Legacy NDC, 2 package rows 20250426_2265ef30-253e-11df-8a39-0800200c9a66.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.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125377 Yervoy ipilimumab 351(a) Rx 2026-07-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0003-2328-22 00003232822 1 VIAL, SINGLE-USE in 1 CARTON (0003-2328-22) / 40 mL in 1 VIAL, SINGLE-USE 2011-03-25 0000-00-00 No No Current