Prescription drug · ANDA
Carboplatin NDC 55150-335
Carboplatin 450 mg/45mL · Injection, Solution · Intravenous · Eugia US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55150-335-00 | 55150033500 | 1 VIAL, MULTI-DOSE in 1 CARTON (55150-335-00) / 45 mL in 1 VIAL, MULTI-DOSEMarketed from Sep 29, 2016 |
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)
- Carboplatin
- Generic name (nonproprietary)
- carboplatin
- Active ingredients
- Carboplatin — 450 mg/45mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Eugia US LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205487
- Marketing start
- Listing expires
- Other FDA classes
- Platinum-containing Compounds (EXT)
- Identifiers
- Product ID 55150-335_5abfcb87-bb02-4384-9c9d-7d0e3e809311SPL ID 5abfcb87-bb02-4384-9c9d-7d0e3e809311SPL set ID 5abfcb87-bb02-4384-9c9d-7d0e3e809311RxCUI 597195UNII BG3F62OND5
- Pharmacologic class
- Platinum-based Drug
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
N455150033500followed by a unit qualifier and the quantityPackage 55150-0335-00. 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 Initial Treatment of Advanced Ovarian Carcinoma Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see CLINICAL STUDIES ). There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival (≥ 3 years) because of the …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205487
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 |
|---|---|---|---|---|
| Carboplatin | Carboplatin 600 mg/60mL | Injection, SolutionIntravenous | Eugia US LLC | 55150-386 |
| Carboplatin | Carboplatin 600 mg/60mL | Injection, SolutionIntravenous | Eugia US LLC | 55150-386 |
| Carboplatin | Carboplatin 50 mg/5mL | Injection, SolutionIntravenous | Eugia US LLC | 55150-333 |
| Carboplatin | Carboplatin 150 mg/15mL | Injection, SolutionIntravenous | Eugia US LLC | 55150-334 |