Prescription drug · NDA
Rozlytrek (Entrectinib) NDC 50242-094
Entrectinib 200 mg/1 · Capsule · Oral · Genentech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50242-094-47 | 50242009447 | 1 BOTTLE in 1 CARTON (50242-094-47) / 90 CAPSULE in 1 BOTTLEMarketed from Aug 15, 2019 · Sample package | |
| 50242-094-90 | 50242009490 | 1 BOTTLE in 1 CARTON (50242-094-90) / 90 CAPSULE in 1 BOTTLEMarketed from Aug 15, 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)
- Rozlytrek
- Generic name (nonproprietary)
- entrectinib
- Active ingredients
- Entrectinib — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Genentech, Inc.NDC labeler code 50242
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212725
- Marketing start
- Listing expires
- Identifiers
- Product ID 50242-094_b93e1fc0-614a-4e49-a91d-a409fb2db9f0SPL ID b93e1fc0-614a-4e49-a91d-a409fb2db9f0SPL set ID c7c71b0c-2549-4495-86b6-c2807fa54908RxCUI 2197867, 2197873, 2197875, 2197877, 2668595, 2668599UNII L5ORF0AN1I
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
N450242009447followed by a unit qualifier and the quantityPackage 50242-0094-47. 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)
ROZLYTREK is a kinase inhibitor indicated for the treatment of: Adult patients with ROS1- positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. ( 1.1 ) Adult and pediatric patients older than 1 month of age with solid tumors that: have a neurotrophic tyrosine receptor kinase ( NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Co…
Excerpt only. Read the full label for complete information.
About NDC 50242-094
- What is NDC 50242-094?
- 50242-094 is the product NDC for Rozlytrek (entrectinib), Entrectinib 200 mg/1 capsule, listed with the FDA by Genentech, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rozlytrek (Entrectinib).
- What is the active ingredient?
- Entrectinib.
- 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 Rozlytrek?
- 2 other product NDCs are listed under this name. See all Rozlytrek NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rozlytrek products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Rozlytrekentrectinib | Entrectinib 50 mg/201 | PelletOral | Genentech, Inc. | 50242-623 | 50242-0623-42 |
| Rozlytrekentrectinib | Entrectinib 100 mg/1 | CapsuleOral | Genentech, Inc. | 50242-091 | 50242-0091-3050242-0091-86 |
Other NDCs under NDA 212725
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 |
|---|---|---|---|---|
| Rozlytrekentrectinib | Entrectinib 100 mg/1 | CapsuleOral | Genentech, Inc. | 50242-091 |