Prescription drug · ANDA

Carboplatin NDC 60505-6282

Carboplatin 10 mg/mL · Injection, Solution · Intravenous · Apotex Corp.

NDC codes

FDA NDC Directory
Product NDC (as listed)60505-6282Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60505-6282Add 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 NDC11-digit (billing)PackageCopy
60505-6282-160505628201605056282011 VIAL, MULTI-DOSE in 1 CARTON (60505-6282-1) / 5 mL in 1 VIAL, MULTI-DOSEMarketed from Jan 10, 2024
60505-6282-360505628203605056282031 VIAL, MULTI-DOSE in 1 CARTON (60505-6282-3) / 15 mL in 1 VIAL, MULTI-DOSEMarketed from Jan 10, 2024
60505-6282-660505628206605056282061 VIAL, MULTI-DOSE in 1 CARTON (60505-6282-6) / 45 mL in 1 VIAL, MULTI-DOSEMarketed from Jan 10, 2024
60505-6282-760505628207605056282071 VIAL, MULTI-DOSE in 1 CARTON (60505-6282-7) / 60 mL in 1 VIAL, MULTI-DOSEMarketed from Jan 10, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Apotex Corp.NDC labeler code 60505
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 60505-6282_0e68e276-b0df-4f03-e063-6394a90a22b9SPL ID 0e68e276-b0df-4f03-e063-6394a90a22b9SPL set ID 1c275825-0275-4c73-b650-e4c1519f13b8RxCUI 597195UNII BG3F62OND5UPC 0360505628261, 0360505628230, 0360505628278
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

N460505628201 followed by a unit qualifier and the quantity

Package 60505-6282-01. 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.

Full label on DailyMed (opens in a new tab)

About NDC 60505-6282

What is NDC 60505-6282?
60505-6282 is the product NDC for Carboplatin, Carboplatin 10 mg/mL injection, solution, listed with the FDA by Apotex Corp.. It has 4 package NDCs, 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?
Apotex Corp., NDC labeler code 60505. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Carboplatin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
CarboplatinCarboplatin 50 mg/5mLInjection, SolutionIntravenousNatco Pharma USA LLC69339-36469339-0364-05
CarboplatinCarboplatin 150 mg/15mLInjection, SolutionIntravenousNatco Pharma USA LLC69339-36569339-0365-15
CarboplatinCarboplatin 450 mg/45mLInjection, SolutionIntravenousNatco Pharma USA LLC69339-36669339-0366-45
CarboplatinCarboplatin 600 mg/60mLInjection, SolutionIntravenousNatco Pharma USA LLC69339-36769339-0367-60
CarboplatinCarboplatin 600 mg/60mLInjection, SolutionIntravenousTeyro Labs Private Limited82511-00682511-0006-60
CarboplatinCarboplatin 10 mg/mLInjection, SolutionIntravenousBPI Labs LLC54288-16454288-0164-01
CarboplatinCarboplatin 10 mg/mLInjection, SolutionIntravenousBPI Labs LLC54288-16554288-0165-01
CarboplatinCarboplatin 10 mg/mLInjection, SolutionIntravenousBPI Labs LLC54288-16654288-0166-01
CarboplatinCarboplatin 10 mg/mLInjection, SolutionIntravenousBPI Labs LLC54288-16754288-0167-01
CarboplatinCarboplatin 10 mg/mLInjection, SolutionIntravenousHospira, Inc.61703-15061703-0150-05

All 32 Carboplatin NDCs

Other NDCs under ANDA 077861

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

FDA NDC Directory listings under ANDA 077861
ProductStrengthForm · routeLabelerProduct NDC
CarboplatinCarboplatin 50 mg/5mLInjection, SolutionIntravenousNatco Pharma USA LLC69339-364
CarboplatinCarboplatin 150 mg/15mLInjection, SolutionIntravenousNatco Pharma USA LLC69339-365
CarboplatinCarboplatin 450 mg/45mLInjection, SolutionIntravenousNatco Pharma USA LLC69339-366
CarboplatinCarboplatin 600 mg/60mLInjection, SolutionIntravenousNatco Pharma USA LLC69339-367
CarboplatinCarboplatin 50 mg/5mLInjection, SolutionIntravenousTeyro Labs Private Limited82511-003
CarboplatinCarboplatin 150 mg/15mLInjection, SolutionIntravenousTeyro Labs Private Limited82511-004
CarboplatinCarboplatin 450 mg/45mLInjection, SolutionIntravenousTeyro Labs Private Limited82511-005
CarboplatinCarboplatin 600 mg/60mLInjection, SolutionIntravenousTeyro Labs Private Limited82511-006

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