Home NDC 71647-001-01 ROTOP - DMSA
Product NDC 71647-001
Requested package NDC 71647-001-01
11-digit product format 716470001
Labeler code 71647
Product ID 71647-001_1965c06d-a95b-430e-8783-de42b08ef56b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Kit for the Preparation of Technetium Tc99m Succimer Injection
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler ROTOP Pharmaka GmbH
Marketing category UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing start 2017-08-08
Marketing end 0000-00-00
Substance 2,3-DIMERCAPTOSUCCINIC ACID
Active strength 1 mg/1
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71647-001-01 ROTOP - DMSA 1 in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1 5 71647-001-01 ROTOP - DMSA 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 71647-001 ROTOP - DMSA (KIT FOR THE PREPARATION OF TECHNETIUM TC99M SUCCIMER INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROTOP PHARMAKA GMBH] 5 Legacy NDC, 2 package rows 20210312_fa643e8a-a8d2-4868-92ad-98dd17e92172.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71647-001-01 71647000101 5 VIAL in 1 CARTON (71647-001-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL 5 vial 2017-08-08 0000-00-00 No No Current