NDC codes

FDA NDC Directory
Product NDC (as listed)61269-410Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61269-0410Add 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
61269-410-2061269041020612690410201 VIAL, SINGLE-DOSE in 1 CARTON (61269-410-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSEMarketed from Jun 1, 2009

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)
Etopophos
Generic name (nonproprietary)
etoposide phosphate
Active ingredients
Etoposide phosphate — 100 mg/1
Dosage form
Injection, Powder, Lyophilized, For solution
Route
Intravenous
Labeler
H2-Pharma, LLCNDC labeler code 61269
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 020457
Marketing start
Listing expires
Other FDA classes
Topoisomerase Inhibitors (Mechanism)
Identifiers
Product ID 61269-410_ef45c859-64fd-4af8-a207-d1048bf7049bSPL ID ef45c859-64fd-4af8-a207-d1048bf7049bSPL set ID 7499fc35-fae8-44ad-bbab-9a1a589bf3eeRxCUI 226719, 1734340UNII 528XYJ8L1N
Pharmacologic class
Topoisomerase 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

N461269041020 followed by a unit qualifier and the quantity

Package 61269-0410-20. 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)

ETOPOPHOS is a topoisomerase inhibitor indicated for the treatment of patients with: Refractory testicular tumors, in combination with other chemotherapeutic drugs. ( 1.1 ) Small cell lung cancer, in combination with cisplatin, as first-line treatment. ( 1.2 ) 1.1 Refractory Testicular Tumors ETOPOPHOS is indicated, in combination with other chemotherapeutic drugs, for treatment of patients with refractory testicular tumors. 1.2 Small Cell Lung Cancer ETOPOPHOS is indicated, in combination with cisplatin, for first-line treatment of patients with small cell lung cancer.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61269-410

What is NDC 61269-410?
61269-410 is the product NDC for Etopophos (etoposide phosphate), Etoposide phosphate 100 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by H2-Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Etopophos (Etoposide phosphate).
What is the active ingredient?
Etoposide phosphate.
Who is the labeler?
H2-Pharma, LLC, NDC labeler code 61269. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Etopophos?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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