Prescription drug · ANDA
Thiotepa NDC 65219-029
Thiotepa 100 mg/1 · Injection, Powder, Lyophilized, For solution · Intracavitary, Intravenous, Intravesical · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65219-029-20 | 65219002920 | 1 VIAL in 1 CARTON (65219-029-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIALMarketed from Apr 11, 2022 |
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 — 100 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intracavitary, Intravenous, Intravesical
- Labeler
- Fresenius Kabi USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214222
- Marketing start
- Listing expires
- Other FDA classes
- Alkylating Activity (Mechanism)
- Identifiers
- Product ID 65219-029_a1ce70f8-1f22-4771-b51a-2e9b12876558SPL ID a1ce70f8-1f22-4771-b51a-2e9b12876558SPL set ID 493410f3-0733-4f76-8050-6529d96f2a5bRxCUI 1660004UNII 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
N465219002920followed by a unit qualifier and the quantityPackage 65219-0029-20. 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)
Thiotepa for injection is an alkylating drug indicated: • 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 ) 1.2 Adenocarcinoma of the Breast or Ovary Thiotepa for injection is indicated for treatment of adenocarcinoma of the breast or ovary. 1.3 Malignant Effusions Thiotepa for injection is indicated for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. 1.4 Superficial Papillary Carcinoma of the Ur…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214222
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 |
|---|---|---|---|---|
| Thiotepa | Thiotepa 15 mg/1 | Injection, Powder, Lyophilized, For solutionIntracavitary, Intravenous, Intravesical | Gland Pharma Limited | 68083-446 |
| Thiotepa | Thiotepa 100 mg/1 | Injection, Powder, Lyophilized, For solutionIntracavitary, Intravenous, Intravesical | Gland Pharma Limited | 68083-503 |
| Thiotepa | Thiotepa 100 mg/1 | Injection, Powder, Lyophilized, For solutionIntracavitary, Intravenous, Intravesical | Dr.Reddy's Laboratories Inc., | 43598-171 |