NephroScan

Product NDC
71083-0020
11-digit product format
710830020
Labeler code
71083
Product ID
71083-0020_ed28b4c6-15f3-495e-9e79-ce9610228aa5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SUCCIMER
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Theragnostics Inc
Application
NDA214993
Marketing category
NDA
Marketing start
2022-02-18
Substance
SUCCIMER
Active strength
1 mg/1
Pharmacologic classes
Lead Chelating Activity [MoA], Lead Chelator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NephroScan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUCCIMER1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDX1U2629QE

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2f5edee6-054b-4e78-9516-4902240bd895Product name120221206
67641ec0-7553-6d3f-05ca-04c54d959119Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71083-0020-1NephroScan1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,15
71083-0020-5NephroScan5 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71083-0020NEPHROSCAN (SUCCIMER) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THERAGNOSTICS INC]5Current NDC, Legacy NDC, 2 package rows20241004_ddd90c4a-5792-49c9-837f-710d1a604742.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71083-0020-1710830020011 in 1 VIAL, SINGLE-DOSEHistorical
71083-0020-5710830020055 VIAL, SINGLE-DOSE in 1 CARTON (71083-0020-5) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71083-0020-1) 2022-02-180000-00-00NoNoCurrent