Prescription drug · NDA
Lazcluze (Lazertinib) NDC 57894-080
Lazertinib 80 mg/1 · Tablet, Film coated · Oral · Janssen Biotech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57894-080-60 | 57894008060 | 1 BOTTLE in 1 CARTON (57894-080-60) / 60 TABLET, FILM COATED in 1 BOTTLEMarketed from Aug 20, 2024 | |
| 57894-080-90 | 57894008090 | 1 BOTTLE in 1 CARTON (57894-080-90) / 90 TABLET, FILM COATED in 1 BOTTLEMarketed from Aug 20, 2024 |
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)
- Lazcluze
- Generic name (nonproprietary)
- lazertinib
- Active ingredients
- Lazertinib — 80 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Janssen Biotech, Inc.NDC labeler code 57894
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 219008
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 57894-080_da4a9239-16d7-46cf-b089-e943e0080015SPL ID da4a9239-16d7-46cf-b089-e943e0080015SPL set ID c417f9ee-2027-4ed5-92ad-3c19266de16cRxCUI 2691156, 2691162, 2691164, 2691166UNII 4A2Y23XK11
- Pharmacologic class
- Kinase 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N457894008060followed by a unit qualifier and the quantityPackage 57894-0080-60. 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 .
Indications (excerpt from the label)
LAZCLUZE, in combination with amivantamab, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . LAZCLUZE is a kinase inhibitor indicated in combination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. ( 1 )…
Excerpt only. Read the full label for complete information.
About NDC 57894-080
- What is NDC 57894-080?
- 57894-080 is the product NDC for Lazcluze (lazertinib), Lazertinib 80 mg/1 tablet, film coated, listed with the FDA by Janssen Biotech, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lazcluze (Lazertinib).
- What is the active ingredient?
- Lazertinib.
- Who is the labeler?
- Janssen Biotech, Inc., NDC labeler code 57894. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lazcluze?
- 1 other product NDC are listed under this name. See all Lazcluze NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lazcluze products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lazcluzelazertinib | Lazertinib 240 mg/1 | Tablet, Film coatedOral | Janssen Biotech, Inc. | 57894-240 | 57894-0240-3057894-0240-99 |
Other NDCs under NDA 219008
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 |
|---|---|---|---|---|
| Lazcluzelazertinib | Lazertinib 240 mg/1 | Tablet, Film coatedOral | Janssen Biotech, Inc. | 57894-240 |