Thiotepa
- Product NDC
- 68083-503
- 11-digit product format
- 680830503
- Labeler code
- 68083
- Product ID
- 68083-503_164faf7b-519a-41f7-a760-eb2a81b9f040
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Thiotepa
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRACAVITARY; INTRAVENOUS; INTRAVESICAL
- Labeler
- Gland Pharma Limited
- Application
- ANDA214222
- Marketing category
- ANDA
- Marketing start
- 2022-01-03
- Substance
- THIOTEPA
- Active strength
- 100 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
- Thiotepa
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| THIOTEPA | 100 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 |
|---|
| 68083-503-01 | Thiotepa | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 7 |
| 68083-503-01 | 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 |
|---|
| 68083-503 | THIOTEPA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED] | 6 | Current NDC, Legacy NDC, 2 package rows | 20220105_6cd6ae89-c553-4328-9262-4363610a1f19.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 |
|---|
| 68083-503-01 | 68083050301 | 1 VIAL in 1 CARTON (68083-503-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 1 vial | 2022-01-03 | 0000-00-00 | No | No | Current |