Prescription drug · NDA
Hycamtin (Topotecan hydrochloride) NDC 0078-0674
Topotecan hydrochloride 4 mg/4mL · Injection, Powder, Lyophilized, For solution · Intravenous · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-0674-61 | 00078067461 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0078-0674-61) / 4 mL in 1 VIAL, SINGLE-DOSEMarketed from Dec 21, 2016 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Hycamtin
- Generic name (nonproprietary)
- topotecan hydrochloride
- Active ingredients
- Topotecan hydrochloride — 4 mg/4mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020671
- Marketing start
- Listing expires
- Other FDA classes
- Topoisomerase Inhibitors (Mechanism)
- Identifiers
- Product ID 0078-0674_e6e4f66b-e398-44d3-a832-e5a809f3e861SPL ID e6e4f66b-e398-44d3-a832-e5a809f3e861SPL set ID eeee060c-a9ec-423e-a374-8484009f8524RxCUI 637550, 1799416UNII 956S425ZCY
- Pharmacologic class
- Topoisomerase Inhibitor
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
N400078067461followed by a unit qualifier and the quantityPackage 00078-0674-61. 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)
HYCAMTIN for injection is a topoisomerase inhibitor indicated for treatment of: Patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy, as a single agent ( 1.1 ) Patients with small cell lung cancer (SCLC) platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy, as a single agent ( 1.2 ) Patients with Stage IV-B, recurrent, or persistent cervical cancer which is not amenable to curative treatment, in combination with cisplatin ( 1.3 ) 1.1 Ovarian Cancer HYCAMTIN ® for injection, as a single agent, is indicated for the treatment of patients with metastatic ovarian cancer after disease prog…
Excerpt only. Read the full label for complete information.
About NDC 0078-0674
- What is NDC 0078-0674?
- 0078-0674 is the product NDC for Hycamtin (topotecan hydrochloride), Topotecan hydrochloride 4 mg/4mL injection, powder, lyophilized, for solution, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hycamtin (Topotecan hydrochloride).
- What is the active ingredient?
- Topotecan hydrochloride.
- Who is the labeler?
- Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hycamtin?
- 2 other product NDCs are listed under this name. See all Hycamtin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hycamtin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hycamtintopotecan | Topotecan hydrochloride .25 mg/1 | CapsuleOral | Sandoz Inc | 66758-101 | 66758-0101-11 |
| Hycamtintopotecan | Topotecan hydrochloride 1 mg/1 | CapsuleOral | Sandoz Inc | 66758-102 | 66758-0102-11 |