Prescription drug · NDA
Alecensa (alectinib hydrochloride) NDC 50242-130
Alectinib hydrochloride 150 mg/1 · Capsule · Oral · Genentech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50242-130-01 | 50242013001 | 1 BOTTLE, PLASTIC in 1 CARTON (50242-130-01) / 240 CAPSULE in 1 BOTTLE, PLASTICMarketed from Dec 11, 2015 | |
| 50242-130-86 | 50242013086 | 1 BOTTLE, PLASTIC in 1 CARTON (50242-130-86) / 240 CAPSULE in 1 BOTTLE, PLASTICMarketed from Oct 10, 2017 · Sample package |
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)
- Alecensa
- Generic name (nonproprietary)
- alectinib hydrochloride
- Active ingredients
- Alectinib hydrochloride — 150 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Genentech, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208434
- Marketing start
- Listing expires
- Other FDA classes
- Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 50242-130_3159555e-f227-4168-9e96-96f5b705fad2SPL ID 3159555e-f227-4168-9e96-96f5b705fad2SPL set ID 42c49deb-713b-427a-9670-08af08adcffbRxCUI 1727479, 1727485UNII P9YY73LO6J
- 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
N450242013001followed by a unit qualifier and the quantityPackage 50242-0130-01. 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 .
Indications (excerpt from the label)
ALECENSA is a kinase inhibitor indicated for: adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive) as detected by an FDA-approved test. ( 1.1 ) treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test. ( 1.2 ) 1.1 Adjuvant Treatment of Resected ALK-Positive Non-Small Cell Lung Cancer (NSCLC) ALECENSA is indicated as adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive), as detected by an FDA-approved test [see…
Excerpt only. Read the full label for complete information.