Thiotepa
- Product NDC
- 54879-014
- 11-digit product format
- 548790014
- Labeler code
- 54879
- Product ID
- 54879-014_edabacc1-6671-42a1-e053-2a95a90a9c5c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Thiotepa
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRACAVITARY; INTRAVENOUS; INTRAVESICAL
- Labeler
- STI Pharma LLC
- Application
- ANDA208242
- Marketing category
- ANDA
- Marketing start
- 2016-10-07
- Marketing end
- 0000-00-00
- Substance
- THIOTEPA
- Active strength
- 15 mg/15mg
- Pharmacologic classes
- Alkylating Activity [MoA], Alkylating Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54879-014-13 | 54879001413 | 15 mg in 1 VIAL, SINGLE-USE (54879-014-13) | 15 mg | 2016-10-07 | 0000-00-00 | No | No | Current |