TEPADINA
- Product NDC
- 70121-2749
- 11-digit product format
- 701212749
- Labeler code
- 70121
- Product ID
- 70121-2749_4f44c872-f02d-48cc-b2a4-4e05d2422b72
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- thiotepa
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRACAVITARY; INTRAVENOUS; INTRAVESICAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- NDA208264
- Marketing category
- NDA
- Marketing start
- 2025-04-18
- Substance
- THIOTEPA
- Active strength
- 200 mg/1
- Pharmacologic classes
- Alkylating Activity [MoA], Alkylating Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 905Z5W3GKH | THIOTEPA | 52-24-4 | THIOTEPA |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70121-2749-1 | 70121274901 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 BOX (70121-2749-1) | 2025-04-18 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| TEPADINA | Amneal Pharmaceuticals LLC | Adienne S.r.l. | BSP Pharmaceuticals SpA | CIT SRL | Eurofins Biolab Srl | Indena SpA | LabAnalysis Life Science srl | NerPharMa S.r.l | 2026-01-30 | HUMAN PRESCRIPTION DRUG LABEL | 30 |
| TEPADINA | Amneal Pharmaceuticals LLC | Adienne S.r.l. | BSP Pharmaceuticals SpA | CIT SRL | Eurofins Biolab Srl | Indena SpA | LabAnalysis Life Science srl | NerPharMa S.r.l | 2025-10-15 | HUMAN PRESCRIPTION DRUG LABEL | 27 |
| TEPADINA | Amneal Pharmaceuticals LLC | Adienne S.r.l. | BSP Pharmaceuticals SpA | CIT SRL | Eurofins Biolab Srl | Indena SpA | LabAnalysis Life Science srl | NerPharMa S.r.l | 2025-04-24 | HUMAN PRESCRIPTION DRUG LABEL | 25 |