Thiotepa
- Product NDC
- 43598-650
- 11-digit product format
- 435980650
- Labeler code
- 43598
- Product ID
- 43598-650_e880a370-00f9-f7c7-a992-64756718360b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Thiotepa
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRACAVITARY; INTRAVENOUS; INTRAVESICAL
- Labeler
- Dr.Reddy's Laboratories Inc.,
- Application
- ANDA210337
- Marketing category
- ANDA
- Marketing start
- 2018-05-04
- 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 | 1660009 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43598-650-11 | Thiotepa | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 7 |
| 43598-650-11 | Thiotepa | 1 in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-650 | THIOTEPA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR.REDDY'S LABORATORIES INC.,] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240802_0def6a5e-4bf5-b1fd-47b7-0f17ecfd9bc2.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 |
|---|
| 43598-650-11 | 43598065011 | 1 VIAL in 1 CARTON (43598-650-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 1 vial | 2018-05-04 | 0000-00-00 | No | No | Current |