Home NDC 71083-0020 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N214993-001 NEPHROSCAN TECHNETIUM TC-99M SUCCIMER N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 4b0b4de00fa7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214993-001 NEPHROSCAN N/A POWDER / INTRAVENOUS RLD, RS 2022-02-18 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base NephroScan
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SUCCIMER 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination DX1U2629QE Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71083-0020-1 NephroScan 1 in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 5 71083-0020-5 NephroScan 5 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 5 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71083-0020 NEPHROSCAN (SUCCIMER) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [THERAGNOSTICS INC] 5 Current NDC, Legacy NDC, 2 package rows 20241004_ddd90c4a-5792-49c9-837f-710d1a604742.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 71083-0020-1 71083002001 1 in 1 VIAL, SINGLE-DOSE Historical 71083-0020-5 71083002005 5 VIAL, SINGLE-DOSE in 1 CARTON (71083-0020-5) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71083-0020-1) 2022-02-18 0000-00-00 No No Current