TEPADINA
- Product NDC
- 70121-1630
- 11-digit product format
- 701211630
- Labeler code
- 70121
- Product ID
- 70121-1630_4f44c872-f02d-48cc-b2a4-4e05d2422b72
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- THIOTEPA
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRACAVITARY; INTRAVENOUS; INTRAVESICAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- NDA208264
- Marketing category
- NDA
- Marketing start
- 2017-08-15
- Substance
- THIOTEPA
- Active strength
- 15 mg/1
- Pharmacologic classes
- Alkylating Activity [MoA], Alkylating Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TEPADINA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| THIOTEPA | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 905Z5W3GKH |
| Rxcui | 1660004, 1660009, 1919209, 1919211, 2712232, 2712234, 2734124, 2734126 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70121-1630-1 | TEPADINA | 1 in 1 BOX | INJECTION, POWDER, FOR SOLUTION | 1 | | 30 |
| 70121-1630-1 | TEPADINA | 1 in 1 VIAL, GLASS | INJECTION, POWDER, FOR SOLUTION | 1 | | 30 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70121-1630 | TEPADINA (THIOTEPA) INJECTION, POWDER, FOR SOLUTION TEPADINA (THIOTEPA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMNEAL PHARMACEUTICALS LLC] | 23 | Current NDC, Legacy NDC, 2 package rows | 20250426_559e353c-2dc0-16ba-e054-00144ff8d46c.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 |
|---|
| 70121-1630-1 | 70121163001 | 1 VIAL, GLASS in 1 BOX (70121-1630-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS | 2017-08-15 | 0000-00-00 | No | No | Current |