simulect

Generic: basiliximab

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name simulect
Generic Name basiliximab
Labeler novartis pharmaceuticals corporation
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

basiliximab 20 mg/5mL

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0331
Product ID 0078-0331_3a12b631-15b1-4b4a-a018-692037cc4709
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA103764
Listing Expiration 2026-12-31
Marketing Start 1998-05-12

Pharmacologic Class

Established (EPC)
interleukin-2 receptor blocking antibody [epc]
Mechanism of Action
interleukin 2 receptor antagonists [moa] interleukin 2 receptor-directed antibody interactions [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00780331
Hyphenated Format 0078-0331

Supplemental Identifiers

RxCUI
1656643 1656646 1656648 1656650
UNII
9927MT646M
NUI
N0000010279 N0000175621 N0000175622

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name simulect (source: ndc)
Generic Name basiliximab (source: ndc)
Application Number BLA103764 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (0078-0331-84) / 5 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

0078-0331-84 1 VIAL, SINGLE-USE in 1 CARTON (0078-0331-84) / 5 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

basiliximab (20 mg/5mL)

Linked Drug Pages (1)

Simulect ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3a12b631-15b1-4b4a-a018-692037cc4709", "openfda": {"nui": ["N0000010279", "N0000175621", "N0000175622"], "unii": ["9927MT646M"], "rxcui": ["1656643", "1656646", "1656648", "1656650"], "spl_set_id": ["1af01887-b69d-444b-91ed-ebfe12784440"], "pharm_class_epc": ["Interleukin-2 Receptor Blocking Antibody [EPC]"], "pharm_class_moa": ["Interleukin 2 Receptor Antagonists [MoA]", "Interleukin 2 Receptor-directed Antibody Interactions [MoA]"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (0078-0331-84)  / 5 mL in 1 VIAL, SINGLE-USE", "package_ndc": "0078-0331-84", "marketing_start_date": "19980512"}], "brand_name": "Simulect", "product_id": "0078-0331_3a12b631-15b1-4b4a-a018-692037cc4709", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Interleukin 2 Receptor Antagonists [MoA]", "Interleukin 2 Receptor-directed Antibody Interactions [MoA]", "Interleukin-2 Receptor Blocking Antibody [EPC]"], "product_ndc": "0078-0331", "generic_name": "basiliximab", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Simulect", "active_ingredients": [{"name": "BASILIXIMAB", "strength": "20 mg/5mL"}], "application_number": "BLA103764", "marketing_category": "BLA", "marketing_start_date": "19980512", "listing_expiration_date": "20261231"}