Prescription drug · ANDA
Thiotepa NDC 25021-246
Thiotepa 15 mg/1.5mL · Injection, Powder, Lyophilized, For solution · Intracavitary, Intravenous, Intravesical · Sagent Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25021-246-02 | 25021024602 | 1 VIAL in 1 CARTON (25021-246-02) / 1.5 mL in 1 VIALMarketed from Jun 15, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Thiotepa
- Generic name (nonproprietary)
- thiotepa
- Active ingredients
- Thiotepa — 15 mg/1.5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intracavitary, Intravenous, Intravesical
- Labeler
- Sagent PharmaceuticalsNDC labeler code 25021
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209150
- Marketing start
- Listing expires
- Other FDA classes
- Alkylating Activity (Mechanism)
- Identifiers
- Product ID 25021-246_94e38a38-8923-499d-bd75-f85754d7c730SPL ID 94e38a38-8923-499d-bd75-f85754d7c730SPL set ID 448c29f1-6d9c-4f8e-8a69-9b85e973e728RxCUI 1660009UNII 905Z5W3GKH
- Pharmacologic class
- Alkylating Drug
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N425021024602followed by a unit qualifier and the quantityPackage 25021-0246-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Thiotepa for Injection has been tried with varying results in the palliation of a wide variety of neoplastic diseases. However, the most consistent results have been seen in the following tumors: Adenocarcinoma of the breast. Adenocarcinoma of the ovary. For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. For the treatment of superficial papillary carcinoma of the urinary bladder. While now largely superseded by other treatments, Thiotepa for Injection has been effective against other lymphomas, such as lymphosarcoma and Hodgkin's disease.
Excerpt only. Read the full label for complete information.
About NDC 25021-246
- What is NDC 25021-246?
- 25021-246 is the product NDC for Thiotepa, Thiotepa 15 mg/1.5mL injection, powder, lyophilized, for solution, listed with the FDA by Sagent Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Thiotepa.
- What is the active ingredient?
- Thiotepa.
- Who is the labeler?
- Sagent Pharmaceuticals, NDC labeler code 25021. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Thiotepa?
- 12 other product NDCs are listed under this name. See all Thiotepa NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Thiotepa products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Thiotepa | Thiotepa 15 mg/1 | Injection, Powder, For solutionIntracavitary, Intravenous, Intravesical | Meitheal Pharmaceuticals Inc | 71288-156 | 71288-0156-05 |
| Thiotepa | Thiotepa 100 mg/1 | Injection, Powder, For solutionIntracavitary, Intravenous, Intravesical | Meitheal Pharmaceuticals Inc | 71288-157 | 71288-0157-10 |
| Thiotepa | Thiotepa 100 mg/1 | Injection, Powder, Lyophilized, For solutionIntracavitary, Intravenous, Intravesical | Hikma Pharmaceuticals USA Inc. | 0143-9292 | 00143-9292-01 |
| Thiotepa | Thiotepa 100 mg/1 | Injection, Powder, Lyophilized, For solutionIntracavitary, Intravenous, Intravesical | Dr.Reddy's Laboratories Inc., | 43598-171 | 43598-0171-11 |
| Thiotepa | Thiotepa 100 mg/1 | Injection, Powder, Lyophilized, For solutionIntracavitary, Intravenous, Intravesical | Fresenius Kabi USA, LLC | 65219-029 | 65219-0029-20 |
| Thiotepa | Thiotepa 100 mg/1 | Injection, Powder, Lyophilized, For solutionIntracavitary, Intravenous, Intravesical | Gland Pharma Limited | 68083-503 | 68083-0503-01 |
| Thiotepa | Thiotepa 15 mg/1 | Injection, Powder, Lyophilized, For solutionIntracavitary, Intravenous, Intravesical | Gland Pharma Limited | 68083-446 | 68083-0446-01 |
| Thiotepa | Thiotepa 15 mg/1 | Injection, Powder, Lyophilized, For solutionIntracavitary, Intravenous, Intravesical | Novadoz Pharmaceuticals LLC | 72205-045 | 72205-0045-01 |
| Thiotepa | Thiotepa 100 mg/1 | Injection, Powder, Lyophilized, For solutionIntracavitary, Intravenous, Intravesical | Novadoz Pharmaceuticals LLC | 72205-046 | 72205-0046-01 |
| Thiotepa | Thiotepa 15 mg/1 | Injection, Powder, Lyophilized, For solutionIntracavitary, Intravenous, Intravesical | Dr.Reddy's Laboratories Inc., | 43598-650 | 43598-0650-11 |