Prescription drug · ANDA
Carboplatin NDC 61703-339
Carboplatin 10 mg/mL · Injection, Solution · Intravenous · Hospira, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61703-339-18 | 61703033918 | 1 VIAL, MULTI-DOSE in 1 CARTON (61703-339-18) / 5 mL in 1 VIAL, MULTI-DOSEMarketed from Oct 14, 2004 | |
| 61703-339-22 | 61703033922 | 1 VIAL, MULTI-DOSE in 1 CARTON (61703-339-22) / 15 mL in 1 VIAL, MULTI-DOSEMarketed from Oct 14, 2004 | |
| 61703-339-50 | 61703033950 | 1 VIAL, MULTI-DOSE in 1 CARTON (61703-339-50) / 45 mL in 1 VIAL, MULTI-DOSEMarketed from Oct 14, 2004 | |
| 61703-339-56 | 61703033956 | 1 VIAL, MULTI-DOSE in 1 CARTON (61703-339-56) / 60 mL in 1 VIAL, MULTI-DOSEMarketed from Nov 23, 2004 |
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 — 10 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Hospira, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076517
- Marketing start
- Listing expires
- Other FDA classes
- Platinum-containing Compounds (EXT)
- Identifiers
- Product ID 61703-339_0ddf4411-7138-412a-908a-fadf22bdfb79SPL ID 0ddf4411-7138-412a-908a-fadf22bdfb79SPL set ID c3ae9880-44bb-4f4e-93d8-8a5e21708a30RxCUI 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
N461703033918followed by a unit qualifier and the quantityPackage 61703-0339-18. 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 Injection 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) becau…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076517
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 | Hospira, Inc. | 61703-150 |
| Carboplatin | Carboplatin 10 mg/mL | Injection, SolutionIntravenous | Hospira, Inc. | 61703-262 |
| Carboplatin | Carboplatin 10 mg/mL | Injection, SolutionIntravenous | Hospira, Inc. | 61703-360 |