Prescription drug · ANDA
Thiotepa NDC 43598-650
Thiotepa 15 mg/1 · Injection, Powder, Lyophilized, For solution · Intracavitary, Intravenous, Intravesical · Dr.Reddy's Laboratories Inc.,
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-650-11 | 4359806501143598065011 | 1 VIAL in 1 CARTON (43598-650-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIALMarketed from May 4, 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
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intracavitary, Intravenous, Intravesical
- Labeler
- Dr.Reddy's Laboratories Inc.,NDC labeler code 43598
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210337
- Marketing start
- Listing expires
- Other FDA classes
- Alkylating Activity (Mechanism)
- Identifiers
- Product ID 43598-650_e880a370-00f9-f7c7-a992-64756718360bSPL ID e880a370-00f9-f7c7-a992-64756718360bSPL set ID 0def6a5e-4bf5-b1fd-47b7-0f17ecfd9bc2RxCUI 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
N443598065011followed by a unit qualifier and the quantityPackage 43598-0650-11. 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, USP 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: 1. Adenocarcinoma of the breast. 2. Adenocarcinoma of the ovary. 3. For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. 4. For the treatment of superficial papillary carcinoma of the urinary bladder. While now largely superseded by other treatments, thiotepa has been effective against other lymphomas, such as lymphosarcoma and Hodgkin’s disease.
Excerpt only. Read the full label for complete information.
About NDC 43598-650
- What is NDC 43598-650?
- 43598-650 is the product NDC for Thiotepa, Thiotepa 15 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Dr.Reddy's Laboratories Inc.,. 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?
- Dr.Reddy's Laboratories Inc.,, NDC labeler code 43598. 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/1.5mL | Injection, Powder, Lyophilized, For solutionIntracavitary, Intravenous, Intravesical | Sagent Pharmaceuticals | 25021-246 | 25021-0246-02 |