Thiotepa
- Product NDC
- 0143-9309
- 11-digit product format
- 001439309
- Labeler code
- 0143
- Product ID
- 0143-9309_43ac39a1-a0e0-48e9-93e2-e7e754bc6038
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Thiotepa
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRACAVITARY; INTRAVENOUS; INTRAVESICAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA075547
- Marketing category
- ANDA
- Marketing start
- 2001-06-01
- 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 |
|---|
| 0143-9309-01 | Thiotepa | 1.5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1.5 | | 4 |
| 0143-9309-01 | Thiotepa | 1 in 1 BOX, UNIT-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9309 | THIOTEPA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20230525_6dc898dc-5949-4aa4-83f8-4bd20c29eb93.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 |
|---|
| 0143-9309-01 | 00143930901 | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9309-01) / 1.5 mL in 1 VIAL | 1 vial | 2001-06-01 | 0000-00-00 | No | No | Current |