Home NDC 52658-7777 LYMPHIR
Product NDC 52658-7777
11-digit product format 526587777
Labeler code 52658
Product ID 52658-7777_2c678496-2a12-3051-e063-6294a90a205e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name denileukin diftitox-cxdl
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Citius Pharmaceuticals, Inc.
Application BLA761312
Marketing category BLA
Marketing start 2025-03-01
Substance DENILEUKIN DIFTITOX
Active strength 300 ug/2mL
Pharmacologic classes CD25-directed Cytotoxin [EPC], Diphtheria Toxin [CS], Interleukin-2 [CS], Recombinant Fusion Proteins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base LYMPHIR
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DENILEUKIN DIFTITOX 300 ug/2mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 25E79B5CTM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2700750 Internal RxNorm lookup 2700756 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 52658-7777-1 LYMPHIR 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 7 52658-7777-1 LYMPHIR 2 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 2 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52658-7777 LYMPHIR (DENILEUKIN DIFTITOX-CXDL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CITIUS PHARMACEUTICALS, INC.] 7 Current NDC, 2 package rows 20250302_ac3613d7-4304-40e7-a3f5-adb8a8adca5d.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LYMPHIR DENILEUKIN DIFTITOX-CXDL Citius Pharmaceuticals, Inc. ac3613d7-4304-40e7-a3f5-adb8a8adca5d 2025-01-23 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761312 ndc (product): 52658-7777
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761312 Lymphir denileukin diftitox-cxdl 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 52658-7777-1 52658777701 1 VIAL, SINGLE-DOSE in 1 CARTON (52658-7777-1) / 2 mL in 1 VIAL, SINGLE-DOSE 2025-03-01 No No Current