FDA.reportPublic FDA data

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

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LYMPHIRDENILEUKIN DIFTITOX-CXDLCitius Pharmaceuticals, Inc.ac3613d7-4304-40e7-a3f5-adb8a8adca5d2025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761312
ndc (product): 52658-7777

Additional Listing Data#

Finished product
Yes
Brand name base
LYMPHIR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DENILEUKIN DIFTITOX300 ug/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
25E79B5CTMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2700750Internal RxNorm lookup
2700756Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ac3613d7-4304-40e7-a3f5-adb8a8adca5dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3b8ac119-a393-4edc-a9a6-a04e61e23efdProduct name120250312
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52658-7777-1LYMPHIR1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,17
52658-7777-1LYMPHIR2 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52658-7777-1EA - Each52658-7777ec329633-53b2-453a-ae79-7ac65b11856f12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52658-7777LYMPHIR (DENILEUKIN DIFTITOX-CXDL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CITIUS PHARMACEUTICALS, INC.]7Current NDC, 2 package rows20250302_ac3613d7-4304-40e7-a3f5-adb8a8adca5d.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761312Lymphirdenileukin diftitox-cxdl351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2700750denileukin diftitox-cxdl 300 MCG InjectionPSNac3613d7-4304-40e7-a3f5-adb8a8adca5d7
2700756LYMPHIR 300 MCG InjectionPSNac3613d7-4304-40e7-a3f5-adb8a8adca5d7
2700756denileukin diftitox-cxdl 0.3 MG Injection [Lymphir]SBDac3613d7-4304-40e7-a3f5-adb8a8adca5d7
2700750denileukin diftitox-cxdl 0.3 MG InjectionSCDac3613d7-4304-40e7-a3f5-adb8a8adca5d7
2700750denileukin diftitox-cxdl 300 MCG InjectionSYac3613d7-4304-40e7-a3f5-adb8a8adca5d7
2700756Lymphir 0.3 MG InjectionSYac3613d7-4304-40e7-a3f5-adb8a8adca5d7
2700756Lymphir 300 MCG InjectionSYac3613d7-4304-40e7-a3f5-adb8a8adca5d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
52658-7777-1526587777011 VIAL, SINGLE-DOSE in 1 CARTON (52658-7777-1) / 2 mL in 1 VIAL, SINGLE-DOSE2025-03-01NoNoCurrent