nephroscan

Generic: succimer

Labeler: theragnostics inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nephroscan
Generic Name succimer
Labeler theragnostics inc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

succimer 1 mg/1

Manufacturer
Theragnostics Inc

Identifiers & Regulatory

Product NDC 71083-0020
Product ID 71083-0020_ed28b4c6-15f3-495e-9e79-ce9610228aa5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214993
Listing Expiration 2026-12-31
Marketing Start 2022-02-18

Pharmacologic Class

Established (EPC)
lead chelator [epc]
Mechanism of Action
lead chelating activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 710830020
Hyphenated Format 71083-0020

Supplemental Identifiers

UNII
DX1U2629QE
NUI
N0000175962 N0000175963

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 nephroscan (source: ndc)
Generic Name succimer (source: ndc)
Application Number NDA214993 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 5 VIAL, SINGLE-DOSE in 1 CARTON (71083-0020-5) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71083-0020-1)
source: ndc

Packages (1)

71083-0020-5 5 VIAL, SINGLE-DOSE in 1 CARTON (71083-0020-5) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71083-0020-1)

Ingredients (1)

succimer (1 mg/1)

Linked Drug Pages (1)

NephroScan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ed28b4c6-15f3-495e-9e79-ce9610228aa5", "openfda": {"nui": ["N0000175962", "N0000175963"], "unii": ["DX1U2629QE"], "spl_set_id": ["ddd90c4a-5792-49c9-837f-710d1a604742"], "pharm_class_epc": ["Lead Chelator [EPC]"], "pharm_class_moa": ["Lead Chelating Activity [MoA]"], "manufacturer_name": ["Theragnostics Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 CARTON (71083-0020-5)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71083-0020-1)", "package_ndc": "71083-0020-5", "marketing_start_date": "20220218"}], "brand_name": "NephroScan", "product_id": "71083-0020_ed28b4c6-15f3-495e-9e79-ce9610228aa5", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Lead Chelating Activity [MoA]", "Lead Chelator [EPC]"], "product_ndc": "71083-0020", "generic_name": "SUCCIMER", "labeler_name": "Theragnostics Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NephroScan", "active_ingredients": [{"name": "SUCCIMER", "strength": "1 mg/1"}], "application_number": "NDA214993", "marketing_category": "NDA", "marketing_start_date": "20220218", "listing_expiration_date": "20261231"}