Prescription drug · NDA
Tepadina (Thiotepa) NDC 70121-1687
Thiotepa 400 mg/1 · Injection, Powder, Lyophilized, For solution · Intracavitary, Intravenous, Intravesical · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70121-1687-1 | 70121168701 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 BOX (70121-1687-1)Marketed from Apr 18, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Tepadina
- Generic name (nonproprietary)
- thiotepa
- Active ingredients
- Thiotepa — 400 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intracavitary, Intravenous, Intravesical
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 70121
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208264
- Marketing start
- Listing expires
- Other FDA classes
- Alkylating Activity (Mechanism)
- Identifiers
- Product ID 70121-1687_4f44c872-f02d-48cc-b2a4-4e05d2422b72SPL ID 4f44c872-f02d-48cc-b2a4-4e05d2422b72SPL set ID 559e353c-2dc0-16ba-e054-00144ff8d46cRxCUI 1660004, 1660009, 1919209, 1919211, 2712232, 2712234, 2734124, 2734126UNII 905Z5W3GKHUPC 0370121163015, 0370121163114, 0370121168713, 0370121274919
- 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
N470121168701followed by a unit qualifier and the quantityPackage 70121-1687-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
TEPADINA (thiotepa) is an alkylating drug indicated: To reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia. (1.1 , 14) For treatment of adenocarcinoma of the breast or ovary. (1.2) For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. (1.3) For treatment of superficial papillary carcinoma of the urinary bladder. (1.4) 1.1 Class 3 Beta-Thalassemia TEPADINA is indicated to reduce the risk of graft rejection when used in co…
Excerpt only. Read the full label for complete information.
About NDC 70121-1687
- What is NDC 70121-1687?
- 70121-1687 is the product NDC for Tepadina (thiotepa), Thiotepa 400 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tepadina (Thiotepa).
- What is the active ingredient?
- Thiotepa.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 70121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tepadina?
- 3 other product NDCs are listed under this name. See all Tepadina NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tepadina products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tepadinathiotepa | Thiotepa 200 mg/1 | Injection, Powder, Lyophilized, For solutionIntracavitary, Intravenous, Intravesical | Amneal Pharmaceuticals LLC | 70121-2749 | 70121-2749-01 |
| Tepadinathiotepa | Thiotepa 100 mg/1 | Injection, Powder, For solutionIntracavitary, Intravenous, Intravesical | Amneal Pharmaceuticals LLC | 70121-1631 | 70121-1631-01 |
| Tepadinathiotepa | Thiotepa 15 mg/1 | Injection, Powder, For solutionIntracavitary, Intravenous, Intravesical | Amneal Pharmaceuticals LLC | 70121-1630 | 70121-1630-01 |
Other NDCs under NDA 208264
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Tepadinathiotepa | Thiotepa 100 mg/1 | Injection, Powder, For solutionIntracavitary, Intravenous, Intravesical | Amneal Pharmaceuticals LLC | 70121-1631 |
| Tepadinathiotepa | Thiotepa 15 mg/1 | Injection, Powder, For solutionIntracavitary, Intravenous, Intravesical | Amneal Pharmaceuticals LLC | 70121-1630 |
| Tepadinathiotepa | Thiotepa 200 mg/1 | Injection, Powder, Lyophilized, For solutionIntracavitary, Intravenous, Intravesical | Amneal Pharmaceuticals LLC | 70121-2749 |