Prescription drug · ANDA
Carboplatin NDC 69339-365
Carboplatin 150 mg/15mL · Injection, Solution · Intravenous · Natco Pharma USA LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69339-365-15 | 69339036515 | 1 VIAL, MULTI-DOSE in 1 CARTON (69339-365-15) / 15 mL in 1 VIAL, MULTI-DOSEMarketed from Jul 2, 2026 |
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 — 150 mg/15mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Natco Pharma USA LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077861
- Marketing start
- Listing expires
- Other FDA classes
- Platinum-containing Compounds (EXT)
- Identifiers
- Product ID 69339-365_4c89cedc-e48b-445c-ad05-54dbe60e4fb0SPL ID 4c89cedc-e48b-445c-ad05-54dbe60e4fb0SPL set ID 4c89cedc-e48b-445c-ad05-54dbe60e4fb0RxCUI 597195UNII BG3F62OND5UPC 0369339364055, 0369339367605, 0369339365151, 0369339366455
- 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
N469339036515followed by a unit qualifier and the quantityPackage 69339-0365-15. 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 077861
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 10 mg/mL | Injection, SolutionIntravenous | Apotex Corp. | 60505-6282 |
| Carboplatin | Carboplatin 150 mg/15mL | Injection, SolutionIntravenous | Teyro Labs Private Limited | 82511-004 |
| Carboplatin | Carboplatin 50 mg/5mL | Injection, SolutionIntravenous | Teyro Labs Private Limited | 82511-003 |
| Carboplatin | Carboplatin 450 mg/45mL | Injection, SolutionIntravenous | Teyro Labs Private Limited | 82511-005 |
| Carboplatin | Carboplatin 600 mg/60mL | Injection, SolutionIntravenous | Teyro Labs Private Limited | 82511-006 |
| Carboplatin | Carboplatin 450 mg/45mL | Injection, SolutionIntravenous | Natco Pharma USA LLC | 69339-366 |
| Carboplatin | Carboplatin 50 mg/5mL | Injection, SolutionIntravenous | Natco Pharma USA LLC | 69339-364 |
| Carboplatin | Carboplatin 600 mg/60mL | Injection, SolutionIntravenous | Natco Pharma USA LLC | 69339-367 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.