Prescription drug · NDA
Pemetrexed (pemetrexed disodium) NDC 0781-3520
Pemetrexed disodium 1000 mg/40mL · Injection, Solution · Intravenous · Sandoz Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Pemetrexed
- Generic name (nonproprietary)
- pemetrexed disodium
- Active ingredients
- Pemetrexed disodium — 1000 mg/40mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Sandoz Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214657
- Marketing start
- Listing expires
- Other FDA classes
- Folic Acid Metabolism Inhibitors (Mechanism)
- Identifiers
- Product ID 0781-3520_764ab64b-c642-4314-83a9-efee79fe83a3SPL ID 764ab64b-c642-4314-83a9-efee79fe83a3SPL set ID 7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab3RxCUI 2602363, 2602365, 2602366UNII 2PKU919BA9
- 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.
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Pemetrexed Injection 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 wit…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 214657
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 |
|---|---|---|---|---|
| Pemetrexedpemetrexed disodium | Pemetrexed disodium 100 mg/4mL | Injection, SolutionIntravenous | Sandoz Inc. | 0781-3518 |
| Pemetrexedpemetrexed disodium | Pemetrexed disodium 500 mg/20mL | Injection, SolutionIntravenous | Sandoz Inc. | 0781-3519 |