Thiotepa
- Product NDC
- 72205-045
- 11-digit product format
- 722050045
- Labeler code
- 72205
- Product ID
- 72205-045_fa8d1c84-357b-433d-8f78-89175c9a8cbc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Thiotepa
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRACAVITARY; INTRAVENOUS; INTRAVESICAL
- Labeler
- Novadoz Pharmaceuticals LLC
- Application
- ANDA213049
- Marketing category
- ANDA
- Marketing start
- 2020-02-01
- Substance
- THIOTEPA
- Active strength
- 15 mg/1
- 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 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 905Z5W3GKH |
| Rxcui | 1660004, 1660009 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72205-045-01 | Thiotepa | 1 in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
| 72205-045-01 | Thiotepa | 1 in 1 BOX | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72205-045 | THIOTEPA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVADOZ PHARMACEUTICALS LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20250419_b702dcc9-dd0e-4386-b1e2-f20562fd2ad9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72205-045-01 | 72205004501 | 1 VIAL, GLASS in 1 BOX (72205-045-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS | 2020-02-01 | 0000-00-00 | No | No | Current |