indium in 111 oxyquinoline

Generic: indium in-111 oxyquinoline

Labeler: bwxt medical ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name indium in 111 oxyquinoline
Generic Name indium in-111 oxyquinoline
Labeler bwxt medical ltd.
Dosage Form LIQUID
Routes
INTRAVENOUS
Active Ingredients

indium in-111 oxyquinoline 1 mCi/mL

Manufacturer
BWXT Medical Ltd.

Identifiers & Regulatory

Product NDC 72536-0920
Product ID 72536-0920_0864f662-e3ce-4426-8c3c-e318f755a89d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202586
Listing Expiration 2026-12-31
Marketing Start 2019-09-27

Pharmacologic Class

Established (EPC)
radioactive diagnostic agent [epc]
Mechanism of Action
radiopharmaceutical activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 725360920
Hyphenated Format 72536-0920

Supplemental Identifiers

UNII
LGX9OL562T
NUI
N0000177914 N0000000205

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 indium in 111 oxyquinoline (source: ndc)
Generic Name indium in-111 oxyquinoline (source: ndc)
Application Number ANDA202586 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mCi/mL
source: ndc
Packaging
  • 1 mL in 1 VIAL, SINGLE-DOSE (72536-0920-1)
source: ndc

Packages (1)

72536-0920-1 1 mL in 1 VIAL, SINGLE-DOSE (72536-0920-1)

Ingredients (1)

indium in-111 oxyquinoline (1 mCi/mL)

Linked Drug Pages (1)

Indium In 111 Oxyquinoline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "0864f662-e3ce-4426-8c3c-e318f755a89d", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["LGX9OL562T"], "spl_set_id": ["7dbfc0f9-0e2e-4aed-85bd-32cf7c74d402"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["BWXT Medical Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 mL in 1 VIAL, SINGLE-DOSE (72536-0920-1)", "package_ndc": "72536-0920-1", "marketing_start_date": "20190927"}], "brand_name": "Indium In 111 Oxyquinoline", "product_id": "72536-0920_0864f662-e3ce-4426-8c3c-e318f755a89d", "dosage_form": "LIQUID", "product_ndc": "72536-0920", "generic_name": "Indium In-111 Oxyquinoline", "labeler_name": "BWXT Medical Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Indium In 111 Oxyquinoline", "active_ingredients": [{"name": "INDIUM IN-111 OXYQUINOLINE", "strength": "1 mCi/mL"}], "application_number": "ANDA202586", "marketing_category": "ANDA", "marketing_start_date": "20190927", "listing_expiration_date": "20261231"}