Prescription drug · NDA
Axtle (pemetrexed) NDC 83831-131
Pemetrexed 100 mg/4mL · Injection, Powder, Lyophilized, For solution · Intravenous · Avyxa Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83831-131-01 | 83831013101 | 1 VIAL in 1 CARTON (83831-131-01) / 4 mL in 1 VIALMarketed from Jan 1, 2025 |
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)
- Axtle
- Generic name (nonproprietary)
- pemetrexed
- Active ingredients
- Pemetrexed — 100 mg/4mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Avyxa Pharma, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210661
- Marketing start
- Listing expires
- Other FDA classes
- Folic Acid Metabolism Inhibitors (Mechanism)
- Identifiers
- Product ID 83831-131_6e125601-ebbb-4fe6-9d9e-80d093b12532SPL ID 6e125601-ebbb-4fe6-9d9e-80d093b12532SPL set ID 9582c46c-d8b0-44b7-a2ee-9c86f5e9b7b1RxCUI 1728072, 1728077, 2699339, 2699341UNII 04Q9AIZ7NOUPC 0383831131014, 0383831132011
- Pharmacologic class
- Folate Analog Metabolic 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 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
N483831013101followed by a unit qualifier and the quantityPackage 83831-0131-01. 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)
AXTLE is a folate analog metabolic inhibitor indicated: in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. ( 1.1 ) in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. ( 1.1 ) as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. ( 1.1 ) as a single agent for the treatment of patients with recurrent, metastatic…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 210661
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 |
|---|---|---|---|---|
| Pemetrexed Dipotassium | Pemetrexed 100 mg/4mL | Injection, Powder, Lyophilized, For solutionIntravenous | Avyxa Pharma, LLC | 83831-111 |
| Pemetrexed Dipotassium | Pemetrexed 500 mg/20mL | Injection, Powder, Lyophilized, For solutionIntravenous | Avyxa Pharma, LLC | 83831-112 |
| Axtlepemetrexed | Pemetrexed 500 mg/20mL | Injection, Powder, Lyophilized, For solutionIntravenous | Avyxa Pharma, LLC | 83831-132 |