Carboplatin NDC 0703-4248

NDC codes

FDA NDC Directory

Product NDC (as listed)0703-4248Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00703-4248Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0703-4248-81	00703424881	1 VIAL, MULTI-DOSE in 1 CARTON (0703-4248-81) / 45 mL in 1 VIAL, MULTI-DOSEMarketed from Dec 9, 2015

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.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077269
Marketing start: Dec 9, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Platinum-containing Compounds (EXT)
Identifiers: Product ID 0703-4248_b943761e-6a46-45a0-bdb4-1fec1e101f8cSPL ID b943761e-6a46-45a0-bdb4-1fec1e101f8cSPL set ID e176b6ef-2ff6-498b-a9d8-7a634d147f37RxCUI 597195UNII BG3F62OND5UPC 0307034246818, 0307034248812, 0307034239810, 0307034244814
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.

How CPT relates to drug billing

NDC on a medical claim

N400703424881 followed by a unit qualifier and the quantity

Package 00703-4248-81. 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 Aug 30, 2022. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077269

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 077269
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.	0703-4239
Carboplatin	Carboplatin 10 mg/mL	Injection, SolutionIntravenous	Teva Parenteral Medicines, Inc.	0703-4244
CARBOplatin	Carboplatin 10 mg/mL	Injection, SolutionIntravenous	Teva Parenteral Medicines, Inc.	0703-4244
Carboplatin	Carboplatin 10 mg/mL	Injection, SolutionIntravenous	Teva Parenteral Medicines, Inc.	0703-4246
CARBOplatin	Carboplatin 10 mg/mL	Injection, SolutionIntravenous	Teva Parenteral Medicines, Inc.	0703-4246