Prescription drug · ANDA
Etoposide NDC 63323-104
Etoposide 20 mg/mL · Injection, Solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-104-05 | 6332301040563323010405 | 10 BOX in 1 CARTON (63323-104-05) / 1 VIAL, MULTI-DOSE in 1 BOX (63323-104-01) / 5 mL in 1 VIAL, MULTI-DOSEMarketed from Jul 18, 2001 | |
| 63323-104-06 | 6332301040663323010406 | 1 VIAL, MULTI-DOSE in 1 CARTON (63323-104-06) / 5 mL in 1 VIAL, MULTI-DOSEMarketed from Sep 9, 2022 | |
| 63323-104-25 | 6332301042563323010425 | 1 VIAL, MULTI-DOSE in 1 CARTON (63323-104-25) / 25 mL in 1 VIAL, MULTI-DOSEMarketed from Jul 18, 2001 | |
| 63323-104-50 | 6332301045063323010450 | 1 VIAL, MULTI-DOSE in 1 CARTON (63323-104-50) / 50 mL in 1 VIAL, MULTI-DOSEMarketed from Jul 18, 2001 |
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, Solution
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074983
- Marketing start
- Listing expires
- Other FDA classes
- Topoisomerase Inhibitors (Mechanism)
- Identifiers
- Product ID 63323-104_25cb14ea-3672-4f9a-9f4a-56052aec57acSPL ID 25cb14ea-3672-4f9a-9f4a-56052aec57acSPL set ID fe870629-104d-4d67-a7c6-f53bc588121eRxCUI 310248UNII 6PLQ3CP4P3UPC 0363323104252, 0363323104504, 0363323104016, 0363323104061
- 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
N463323010405followed by a unit qualifier and the quantityPackage 63323-0104-05. 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. Adequate data on the use of etoposide capsules in the treatment of testicular cancer are not available. Small Cell Lung Cancer Etoposide Injection, USP and/or capsules 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.
About NDC 63323-104
- What is NDC 63323-104?
- 63323-104 is the product NDC for Etoposide, Etoposide 20 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Etoposide.
- What is the active ingredient?
- Etoposide.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Etoposide?
- 13 other product NDCs are listed under this name. See all Etoposide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Etoposide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Etoposide | Etoposide 20 mg/mL | Injection, Solution, ConcentrateIntravenous | BluePoint Laboratories | 68001-681 | 68001-0681-25 |
| Etoposide | Etoposide 20 mg/mL | Injection, Solution, ConcentrateIntravenous | BluePoint Laboratories | 68001-682 | 68001-0682-26 |
| Etoposide | Etoposide 20 mg/mL | Injection, Solution, ConcentrateIntravenous | BluePoint Laboratories | 68001-683 | 68001-0683-27 |
| Etoposide | Etoposide 20 mg/mL | Injection, Solution, ConcentrateIntravenous | Meitheal Pharmaceuticals Inc. | 71288-175 | 71288-0175-05 |
| Etoposide | Etoposide 20 mg/mL | Injection, Solution, ConcentrateIntravenous | Meitheal Pharmaceuticals Inc. | 71288-176 | 71288-0176-25 |
| Etoposide | Etoposide 20 mg/mL | Injection, Solution, ConcentrateIntravenous | Meitheal Pharmaceuticals Inc. | 71288-177 | 71288-0177-50 |
| Etoposide | Etoposide 20 mg/mL | InjectionIntravenous | Accord Healthcare Inc. | 16729-114 | 16729-0114-0816729-0114-1116729-0114-31 |
| Etoposide | Etoposide 20 mg/mL | InjectionIntravenous | BluePoint Laboratories | 68001-265 | 68001-0265-2568001-0265-2668001-0265-27 |
| Etoposide | Etoposide 50 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-3266 | 00378-3266-94 |
| Etoposide | Etoposide 20 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9511 | 00143-9511-01 |