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 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
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 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
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 2026-08-01
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