Prescription drug · BLA
Trodelvy (sacituzumab govitecan) NDC 55135-132
Sacituzumab govitecan 180 mg/1 · Powder, For solution · Intravenous · Gilead Sciences, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55135-132-01 | 55135013201 | 1 VIAL in 1 BOX (55135-132-01) / 1 POWDER, FOR SOLUTION in 1 VIALMarketed from Apr 23, 2020 |
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)
- Trodelvy
- Generic name (nonproprietary)
- sacituzumab govitecan
- Active ingredients
- Sacituzumab govitecan — 180 mg/1
- Dosage form
- Powder, For solution
- Route
- Intravenous
- Labeler
- Gilead Sciences, Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761115
- Marketing start
- Listing expires
- Identifiers
- Product ID 55135-132_2085d741-19ba-4115-bbe9-0debac82c204SPL ID 2085d741-19ba-4115-bbe9-0debac82c204SPL set ID 57a597d2-03f0-472e-b148-016d7169169dRxCUI 2360534, 2360539UNII M9BYU8XDQ6
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
N455135013201followed by a unit qualifier and the quantityPackage 55135-0132-01. 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)
TRODELVY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated: Locally Advanced or Metastatic Triple-Negative Breast Cancer First Line As a single agent for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1 or PD-L1 inhibitor-based therapy. ( 1.1 , 14.1 ) In combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥ 10) as determined by an FDA-authorized test. ( 1.1 , 14.1 ) Second Line or Later For the t…
Excerpt only. Read the full label for complete information.