Home NDC 0078-0331 Simulect
Product NDC 0078-0331
11-digit product format 000780331
Labeler code 0078
Product ID 0078-0331_3a12b631-15b1-4b4a-a018-692037cc4709
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name basiliximab
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Novartis Pharmaceuticals Corporation
Application BLA103764
Marketing category BLA
Marketing start 1998-05-12
Substance BASILIXIMAB
Active strength 20 mg/5mL
Pharmacologic classes Interleukin 2 Receptor Antagonists [MoA], Interleukin 2 Receptor-directed Antibody Interactions [MoA], Interleukin-2 Receptor Blocking Antibody [EPC]
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Simulect BASILIXIMAB Novartis Pharmaceuticals Corporation 1af01887-b69d-444b-91ed-ebfe12784440 2025-12-12 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA103764 ndc (product): 0078-0331
Additional Listing Data#
Finished product Yes
Brand name base Simulect
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BASILIXIMAB 20 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9927MT646M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1656643 Internal RxNorm lookup 1656646 Internal RxNorm lookup 1656648 Internal RxNorm lookup 1656650 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0078-0331-84 Simulect 5 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, FOR SOLUTION 5 18 0078-0331-84 Simulect 1 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 1 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BASILIXIMAB ACTIVE INGREDIENT 9927MT646M SIMULECT (BASILIXIMAB) INJECTION, POWDER, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 3 BASILIXIMAB ACTIVE MOIETY 9927MT646M SIMULECT (BASILIXIMAB) INJECTION, POWDER, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 3 GLYCINE INACTIVE INGREDIENT TE7660XO1C SIMULECT (BASILIXIMAB) INJECTION, POWDER, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 3 MANNITOL INACTIVE INGREDIENT 3OWL53L36A SIMULECT (BASILIXIMAB) INJECTION, POWDER, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 3 POTASSIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 4J9FJ0HL51 SIMULECT (BASILIXIMAB) INJECTION, POWDER, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 3 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X SIMULECT (BASILIXIMAB) INJECTION, POWDER, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 3 SODIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT 22ADO53M6F SIMULECT (BASILIXIMAB) INJECTION, POWDER, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 3 SUCROSE INACTIVE INGREDIENT C151H8M554 SIMULECT (BASILIXIMAB) INJECTION, POWDER, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0331 SIMULECT (BASILIXIMAB) INJECTION, POWDER, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 16 Current NDC, Legacy NDC, 2 package rows 20250122_1af01887-b69d-444b-91ed-ebfe12784440.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103764 Simulect basiliximab 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 0078-0331-84 00078033184 1 VIAL, SINGLE-USE in 1 CARTON (0078-0331-84) / 5 mL in 1 VIAL, SINGLE-USE 1998-05-12 0000-00-00 No No Current