Home NDC 0003-2328-22 YERVOY
Product NDC 0003-2328
Requested package NDC 0003-2328-22
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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base YERVOY
Listing expiration 2026-12-31 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
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 2026-06-01
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