ROTOP - DMSA
- Product NDC
- 71647-001
- 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
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 |