NDC 71647-001

ROTOP - DMSA

Kit For The Preparation Of Technetium Tc99m Succimer Injection

ROTOP - DMSA is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Rotop Pharmaka Gmbh. The primary component is 2,3-dimercaptosuccinic Acid.

Product ID71647-001_1965c06d-a95b-430e-8783-de42b08ef56b
NDC71647-001
Product TypeHuman Prescription Drug
Proprietary NameROTOP - DMSA
Generic NameKit For The Preparation Of Technetium Tc99m Succimer Injection
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-08-08
Marketing CategoryUNAPPROVED DRUG FOR USE IN DRUG SHORTAGE / UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Labeler NameROTOP Pharmaka GmbH
Substance Name2,3-DIMERCAPTOSUCCINIC ACID
Active Ingredient Strength1 mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 71647-001-01

5 VIAL in 1 CARTON (71647-001-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
Marketing Start Date2017-08-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71647-001-01 [71647000101]

ROTOP - DMSA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryUnapproved drug for use in drug shor
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-08

Drug Details

Active Ingredients

IngredientStrength
2,3-DIMERCAPTOSUCCINIC ACID1 mg/1

OpenFDA Data

SPL SET ID:fa643e8a-a8d2-4868-92ad-98dd17e92172
Manufacturer
UNII

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