Thiotepa
- Product NDC
- 25021-246
- 11-digit product format
- 250210246
- Labeler code
- 25021
- Product ID
- 25021-246_94e38a38-8923-499d-bd75-f85754d7c730
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Thiotepa
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRACAVITARY; INTRAVENOUS; INTRAVESICAL
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA209150
- Marketing category
- ANDA
- Marketing start
- 2018-06-15
- Substance
- THIOTEPA
- Active strength
- 15 mg/1.5mL
- Pharmacologic classes
- Alkylating Activity [MoA], Alkylating Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Thiotepa
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| THIOTEPA | 15 mg/1.5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 905Z5W3GKH |
| Rxcui | 1660009 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 25021-246-02 | Thiotepa | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 4 |
| 25021-246-02 | Thiotepa | 1.5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1.5 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25021-246 | THIOTEPA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS] | 3 | Current NDC, Legacy NDC, 2 package rows | 20210819_448c29f1-6d9c-4f8e-8a69-9b85e973e728.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 25021-246-02 | 25021024602 | 1 VIAL in 1 CARTON (25021-246-02) / 1.5 mL in 1 VIAL | 1 vial | 2018-06-15 | 0000-00-00 | No | No | Current |