Prescription drug · ANDA
Etoposide NDC 0143-9512
Etoposide 20 mg/mL · Injection · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9512-01 | 0014395120100143951201 | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9512-01) / 50 mL in 1 VIALMarketed from Oct 23, 2017 |
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)
- Etoposide
- Generic name (nonproprietary)
- etoposide
- Active ingredients
- Etoposide — 20 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074290
- Marketing start
- Listing expires
- Other FDA classes
- Topoisomerase Inhibitors (Mechanism)
- Identifiers
- Product ID 0143-9512_15cf77cf-4207-463d-b6ef-16163db5afb9SPL ID 15cf77cf-4207-463d-b6ef-16163db5afb9SPL set ID 6dfedeff-a807-4405-a482-2f7109ad31c9RxCUI 310248UNII 6PLQ3CP4P3
- 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
N400143951201followed by a unit qualifier and the quantityPackage 00143-9512-01. 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 . 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 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 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 0143-9512
- What is NDC 0143-9512?
- 0143-9512 is the product NDC for Etoposide, Etoposide 20 mg/mL injection, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, 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?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. 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 | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 63323-104 | 63323-0104-0563323-0104-0663323-0104-25+1 more |
Other NDCs under ANDA 074290
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 | Hikma Pharmaceuticals USA Inc. | 0143-9376 |
| Etoposide | Etoposide 20 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9510 |
| Etoposide | Etoposide 20 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9511 |