Carboplatin NDC 68083-193

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-193Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0193Add 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
68083-193-01	68083019301	1 VIAL, MULTI-DOSE in 1 CARTON (68083-193-01) / 60 mL in 1 VIAL, MULTI-DOSEMarketed from Feb 20, 2017

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: Gland Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207324
Marketing start: Feb 20, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Platinum-containing Compounds (EXT)
Identifiers: Product ID 68083-193_5af07c55-5bef-4da3-91fa-9b3d8d1253d3SPL ID 5af07c55-5bef-4da3-91fa-9b3d8d1253d3SPL set ID 9eb057eb-29ce-40d2-9ac8-ed107f25f5abRxCUI 597195UNII BG3F62OND5UPC 0368083192013, 0368083193010, 0368083191016
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

N468083019301 followed by a unit qualifier and the quantity

Package 68083-0193-01. 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 Nov 9, 2023. 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 207324

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

FDA NDC Directory listings under ANDA 207324
Product	Strength	Form · route	Labeler	Product NDC
Carboplatin	Carboplatin 10 mg/mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-191
Carboplatin	Carboplatin 10 mg/mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-190
Carboplatin	Carboplatin 10 mg/mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-192
Carboplatin	Carboplatin 10 mg/mL	Injection, SolutionIntravenous	BPI Labs LLC	54288-164
Carboplatin	Carboplatin 10 mg/mL	Injection, SolutionIntravenous	BPI Labs LLC	54288-165
Carboplatin	Carboplatin 10 mg/mL	Injection, SolutionIntravenous	BPI Labs LLC	54288-166
Carboplatin	Carboplatin 10 mg/mL	Injection, SolutionIntravenous	BPI Labs LLC	54288-167