Prescription drug · BLA
Kadcyla (Ado-trastuzumab emtansine) NDC 50242-087
Trastuzumab emtansine 20 mg/mL · Injection, Powder, Lyophilized, For solution · Intravenous · Genentech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50242-087-01 | 50242008701 | 1 VIAL, SINGLE-USE in 1 CARTON (50242-087-01) / 8 mL in 1 VIAL, SINGLE-USEMarketed from Feb 22, 2013 |
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)
- Kadcyla
- Generic name (nonproprietary)
- ado-trastuzumab emtansine
- Active ingredients
- Trastuzumab emtansine — 20 mg/mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Genentech, Inc.NDC labeler code 50242
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125427
- Marketing start
- Listing expires
- Identifiers
- Product ID 50242-087_27ab596b-f625-4866-b65a-54508ffce760SPL ID 27ab596b-f625-4866-b65a-54508ffce760SPL set ID 23f3c1f4-0fc8-4804-a9e3-04cf25dd302eRxCUI 1658084, 1658087, 1658089, 1658091UNII SE2KH7T06F
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
N450242008701followed by a unit qualifier and the quantityPackage 50242-0087-01. 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)
KADCYLA is a HER2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for: the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: received prior therapy for metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy. ( 1.1 ) the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. ( 1.2 ) Select patients for therapy based on an FDA-authorized test for KADCYLA [see Dosage and Adm…
Excerpt only. Read the full label for complete information.
About NDC 50242-087
- What is NDC 50242-087?
- 50242-087 is the product NDC for Kadcyla (ado-trastuzumab emtansine), Trastuzumab emtansine 20 mg/mL injection, powder, lyophilized, for solution, listed with the FDA by Genentech, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Kadcyla (Ado-trastuzumab emtansine).
- What is the active ingredient?
- Trastuzumab emtansine.
- Who is the labeler?
- Genentech, Inc., NDC labeler code 50242. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Kadcyla?
- 1 other product NDC are listed under this name. See all Kadcyla NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Kadcyla products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Kadcylaado-trastuzumab emtansine | Trastuzumab emtansine 20 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Genentech, Inc. | 50242-088 | 50242-0088-01 |
Other NDCs under BLA 125427
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 |
|---|---|---|---|---|
| Kadcylaado-trastuzumab emtansine | Trastuzumab emtansine 20 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Genentech, Inc. | 50242-088 |