Prescription drug · ANDA
CARBOplatin NDC 0703-4246
Carboplatin 10 mg/mL · Injection, Solution · Intravenous · Teva Parenteral Medicines, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0703-4246-01 | 0070342460100703424601 | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-4246-01) / 15 mL in 1 VIAL, MULTI-DOSEMarketed from May 1, 2006 |
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)
- CARBOplatin
- Generic name (nonproprietary)
- carboplatin
- Active ingredients
- Carboplatin — 10 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Teva Parenteral Medicines, Inc.NDC labeler code 0703
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077269
- Marketing start
- Listing expires
- Other FDA classes
- Platinum-containing Compounds (EXT)
- Identifiers
- Product ID 0703-4246_bed4c1cf-f3ef-4faa-b2a4-24ee9a9879dfSPL ID bed4c1cf-f3ef-4faa-b2a4-24ee9a9879dfSPL set ID f330f5a2-2cad-402f-bcbb-26245a753276RxCUI 597195UNII BG3F62OND5UPC 0307034244012, 0307034246016, 0307034248010
- 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
N400703424601followed by a unit qualifier and the quantityPackage 00703-4246-01. 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 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.
About NDC 0703-4246
- What is NDC 0703-4246?
- 0703-4246 is the product NDC for CARBOplatin, Carboplatin 10 mg/mL injection, solution, listed with the FDA by Teva Parenteral Medicines, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- CARBOplatin.
- What is the active ingredient?
- Carboplatin.
- Who is the labeler?
- Teva Parenteral Medicines, Inc., NDC labeler code 0703. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for CARBOplatin?
- 31 other product NDCs are listed under this name. See all CARBOplatin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other CARBOplatin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Carboplatin | Carboplatin 50 mg/5mL | Injection, SolutionIntravenous | Natco Pharma USA LLC | 69339-364 | 69339-0364-05 |
| Carboplatin | Carboplatin 150 mg/15mL | Injection, SolutionIntravenous | Natco Pharma USA LLC | 69339-365 | 69339-0365-15 |
| Carboplatin | Carboplatin 450 mg/45mL | Injection, SolutionIntravenous | Natco Pharma USA LLC | 69339-366 | 69339-0366-45 |
| Carboplatin | Carboplatin 600 mg/60mL | Injection, SolutionIntravenous | Natco Pharma USA LLC | 69339-367 | 69339-0367-60 |
| Carboplatin | Carboplatin 600 mg/60mL | Injection, SolutionIntravenous | Teyro Labs Private Limited | 82511-006 | 82511-0006-60 |
| Carboplatin | Carboplatin 10 mg/mL | Injection, SolutionIntravenous | BPI Labs LLC | 54288-164 | 54288-0164-01 |
| Carboplatin | Carboplatin 10 mg/mL | Injection, SolutionIntravenous | BPI Labs LLC | 54288-165 | 54288-0165-01 |
| Carboplatin | Carboplatin 10 mg/mL | Injection, SolutionIntravenous | BPI Labs LLC | 54288-166 | 54288-0166-01 |
| Carboplatin | Carboplatin 10 mg/mL | Injection, SolutionIntravenous | BPI Labs LLC | 54288-167 | 54288-0167-01 |
| Carboplatin | Carboplatin 10 mg/mL | Injection, SolutionIntravenous | Hospira, Inc. | 61703-150 | 61703-0150-05 |
Other NDCs under ANDA 077269
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 | Teva Parenteral Medicines, Inc. | 0703-4239 |
| CARBOplatin | Carboplatin 10 mg/mL | Injection, SolutionIntravenous | Teva Parenteral Medicines, Inc. | 0703-4244 |
| Carboplatin | Carboplatin 10 mg/mL | Injection, SolutionIntravenous | Teva Parenteral Medicines, Inc. | 0703-4248 |