Prescription drug · BLA
Herceptin Hylecta (Trastuzumab and hyaluronidase-oysk) NDC 50242-077
Trastuzumab 600 mg/5mL; Hyaluronidase (Human recombinant) 10000 U/5mL · Injection, Solution · Subcutaneous · Genentech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50242-077-01 | 50242007701 | 1 VIAL, SINGLE-DOSE in 1 CARTON (50242-077-01) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 28, 2019 |
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)
- Herceptin Hylecta
- Generic name (nonproprietary)
- trastuzumab and hyaluronidase-oysk
- Active ingredients
- Trastuzumab — 600 mg/5mLHyaluronidase (Human recombinant) — 10000 U/5mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Genentech, Inc.NDC labeler code 50242
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761106
- Marketing start
- Listing expires
- Other FDA classes
- Glycoside Hydrolases (Chemical structure)HER2/Neu/cerbB2 Antagonists (Mechanism)
- Identifiers
- Product ID 50242-077_93f61cbf-140d-448c-a241-f72d6fd80992SPL ID 93f61cbf-140d-448c-a241-f72d6fd80992
- Pharmacologic class
- Endoglycosidase; HER2/neu Receptor Antagonist
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
N450242007701followed by a unit qualifier and the quantityPackage 50242-0077-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 50242-077
- What is NDC 50242-077?
- 50242-077 is the product NDC for Herceptin Hylecta, Trastuzumab 600 mg/5mL; Hyaluronidase (Human recombinant) 10000 U/5mL injection, 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?
- Herceptin Hylecta (Trastuzumab and hyaluronidase-oysk).
- What is the active ingredient?
- Trastuzumab, Hyaluronidase (Human recombinant).
- 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 Herceptin Hylecta?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.