NDC codes

FDA NDC Directory
Product NDC (as listed)0480-4516Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00480-4516Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0480-4516-01004804516011 VIAL, SINGLE-DOSE in 1 CARTON (0480-4516-01) / 4 mL in 1 VIAL, SINGLE-DOSEMarketed from Jun 1, 2022

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Pemetrexed
Generic name (nonproprietary)
pemetrexed
Active ingredients
Pemetrexed monohydrate — 25 mg/mL
Dosage form
Solution, Concentrate
Route
Intravenous
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 208419
Marketing start
Listing expires
Other FDA classes
Folic Acid Metabolism Inhibitors (Mechanism)
Identifiers
Product ID 0480-4516_21155bd2-118e-4ce6-adb8-dddc69ae34c7SPL ID 21155bd2-118e-4ce6-adb8-dddc69ae34c7SPL set ID 8b660f68-b770-4e0a-b2f9-25e663deecc3RxCUI 2602363, 2602365, 2602366UNII 236Y2F7D9J
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.

How CPT relates to drug billing

NDC on a medical claim

N400480451601 followed by a unit qualifier and the quantity

Package 00480-4516-01. 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)

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 epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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