Prescription drug · ANDA
Etoposide NDC 16729-114
Etoposide 20 mg/mL · Injection · Intravenous · Accord Healthcare Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16729-114-08 | 16729011408 | 1 VIAL, MULTI-DOSE in 1 BOX (16729-114-08) / 25 mL in 1 VIAL, MULTI-DOSEMarketed from Mar 3, 2015 | |
| 16729-114-11 | 16729011411 | 1 VIAL, MULTI-DOSE in 1 BOX (16729-114-11) / 50 mL in 1 VIAL, MULTI-DOSEMarketed from Mar 3, 2015 | |
| 16729-114-31 | 16729011431 | 1 VIAL, MULTI-DOSE in 1 BOX (16729-114-31) / 5 mL in 1 VIAL, MULTI-DOSEMarketed from Mar 22, 2015 |
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)
- Etoposide
- Generic name (nonproprietary)
- etoposide
- Active ingredients
- Etoposide — 20 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Accord Healthcare Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074513
- Marketing start
- Listing expires
- Other FDA classes
- Topoisomerase Inhibitors (Mechanism)
- Identifiers
- Product ID 16729-114_364ac37e-94f0-0dad-e063-6394a90aae33SPL ID 364ac37e-94f0-0dad-e063-6394a90aae33SPL set ID 4f850eb2-3542-43a0-90e8-bb37fa05cf15RxCUI 310248UNII 6PLQ3CP4P3UPC 0316729114318, 0316729114110, 0316729114080
- 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.
- NDC on a medical claim
N416729011408followed by a unit qualifier and the quantityPackage 16729-0114-08. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Etoposide Injection USP is indicated in the management of the following neoplasms: Refractory Testicular Tumors Etoposide Injection USP in combination therapy with other approved chemotherapeutic agents in patients with refractory testicular tumors who have already received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy. Small Cell Lung Cancer Etoposide Injection USP in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 074513
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 |
|---|---|---|---|---|
| Etoposide | Etoposide 20 mg/mL | InjectionIntravenous | BluePoint Laboratories | 68001-265 |