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Carboplatin
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Platinum-based Drug [EPC] | EPC | 7 members — no class page |
| Platinum-containing Compounds [EXT] | EPC | 7 members — no class page |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 077861-001 | CARBOPLATIN | INJECTABLE | CARBOPLATIN | Prescription | AP | ||
| 077861-002 | CARBOPLATIN | INJECTABLE | CARBOPLATIN | Prescription | AP | ||
| 077861-003 | CARBOPLATIN | INJECTABLE | CARBOPLATIN | Prescription | AP | ||
| 077861-004 | CARBOPLATIN | INJECTABLE | CARBOPLATIN | Prescription | AP |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — bioequivalence demonstrated (parenteral aqueous solutions)
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 2 | Manufacturing (CMC) | Approved | June 16, 2023 | Unknown |
| Supplement | 1 | Labeling | Approved | March 5, 2020 | Standard |
| Original application | 1 | Approved | January 18, 2007 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250130). This is the manufacturer's labelling text, not a summary and not advice.
Boxed Warning
openFDA Drug LabelingWARNING Carboplatin Injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate treatment facilities are readily available. Bone marrow suppression is dose related and may be severe, resulting in infection and/or bleeding. Anemia may be cumulative and may require transfusion support. Vomiting is another frequent drug-related side effect. Anaphylactic-like reactions to Carboplatin Injection have been reported and may occur within minutes of Carboplatin Injection administration. Epinephrine, corticosteroids, and antihistamines have been employed to alleviate symptoms.
Indications and Usage
openFDA Drug LabelingINDICATIONS: 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 small number of patients with these outcomes: the small number of patients with residual tumor <2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup. Secondary Treatment of Advanced Ovarian Carcinoma Carboplatin Injection is indicated for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with cisplatin. Within the group of patients previously treated with cisplatin, those who have developed progressive disease while receiving cisplatin therapy may have a decreased response rate.
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 small number of patients with these outcomes: the small number of patients with residual tumor <2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup.
Secondary Treatment of Advanced Ovarian Carcinoma Carboplatin Injection is indicated for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with cisplatin. Within the group of patients previously treated with cisplatin, those who have developed progressive disease while receiving cisplatin therapy may have a decreased response rate.
Dosage and Administration
openFDA Drug LabelingDOSAGE AND ADMINISTRATION NOTE: Aluminum reacts with carboplatin causing precipitate formation and loss of potency, therefore, needles or intravenous sets containing aluminum parts that may come in contact with the drug must not be used for the preparation or administration of carboplatin injection. Single-Agent Therapy Carboplatin injection, as a single agent, has been shown to be effective in patients with recurrent ovarian carcinoma at a dosage of 360 mg/m 2 intravenous on day 1 every 4 weeks (alternatively see Formula Dosing ). In general, however, single intermittent courses of carboplatin injection should not be repeated until the neutrophil count is at least 2,000 and the platelet count is at least 100,000. Combination Therapy with Cyclophosphamide In the chemotherapy of advanced ovarian cancer, an effective combination for previously untreated patients consists of: Carboplatin injection - 300 mg/m 2 intravenous on day 1 every 4 weeks for 6 cycles (alternatively see Formula Dosing ). Cyclophosphamide - 600 mg/m 2 intravenous on day 1 every 4 weeks for 6 cycles. For directions regarding the use and administration of cyclophosphamide please refer to its package insert (see CLINICAL STUDIES ). Intermittent courses of carboplatin injection in combination with cyclophosphamide should not be repeated until the neutrophil count is at least 2,000 and the platelet count is at least 100,000. Dose Adjustment Recommendations Pretreatment platelet count and performance status are important prognostic factors for severity of myelosuppression in previously treated patients. The suggested dose adjustments for single agent or combination therapy shown in the table below are modified from controlled trials in previously treated and untreated patients with ovarian carcinoma. Blood counts were done weekly, and the recommendations are based on the lowest post-treatment platelet or neutrophil value. * Percentages apply to carboplatin injection as a single agent or to both carboplatin and cyclophosphamide in combination. In the controlled studies, dosages were also adjusted at a lower level (50% to 60%) for severe myelosuppression. Escalations above 125% were not recommended for these studies. Platelets Neutrophils Adjusted Dose* (From Prior Course) >100,000 >2,000 125% 50 to 100,000 500 to 2,000 No Adjustment <50,000 <500 75% Carboplatin injection is usually administered by an infusion lasting 15 minutes or longer. No pre- or post-treatment hydration or forced diuresis is required. Patients with Impaired Kidney Function Patients with creatinine clearance values below 60 mL/min are at increased risk of severe bone marrow suppression. In renally-impaired patients who received single-agent carboplatin therapy, the incidence of severe leukopenia, neutropenia, or thrombocytopenia has been about 25% when the dosage modifications in the table below have been used. Baseline Creatinine Clearance Recommended Dose on Day 1 41 to 59 mL/min 250 mg/m 2 16 to 40 mL/min 200 mg/m 2 The data available for patients with severely impaired kidney function (creatinine clearance below 15 mL/min) are too limited to permit a recommendation for treatment. These dosing recommendations apply to the initial course of treatment. Subsequent dosages should be adjusted according to the patient’s tolerance based on the degree of bone marrow suppression. Formula Dosing Another approach for determining the initial dose of carboplatin injection is the use of mathematical formulae, which are based on a patient’s pre-existing renal function or renal function and desired platelet nadir. Renal excretion is the major route of elimination for carboplatin (see CLINICAL PHARMACOLOGY ). The use of dosing formulae, as compared to empirical dose calculation based on body surface area, allows compensation for patient variations in pretreatment renal function that might otherwise result in either underdosing (in patients with above average renal function) or overdosing (in patients with imp …
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS Carboplatin injection is contraindicated in patients with a history of severe allergic reactions to cisplatin or other platinum-containing compounds, or mannitol. Carboplatin injection should not be employed in patients with severe bone marrow depression or significant bleeding.
Warnings and Cautions
openFDA Drug LabelingPRECAUTIONS General Needles or intravenous administration sets containing aluminium parts that may come in contact with carboplatin injection should not be used for the preparation or administration of the drug. Aluminium can react with carboplatin causing precipitate formation and loss of potency. Drug Interactions The renal effects of nephrotoxic compounds may be potentiated by carboplatin. Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of carboplatin has not been studied, but compounds with similar mechanisms of action and mutagenicity profiles have been reported to be carcinogenic. Carboplatin has been shown to be mutagenic both in vitro and in vivo . It has also been shown to be embryotoxic and teratogenic in rats receiving the drug during organogenesis. Secondary malignancies have been reported in association with multi-drug therapy. Pregnancy Pregnancy Category D See WARNINGS . Nursing Mothers It is not known whether carboplatin is excreted in human milk. Because there is a possibility of toxicity in nursing infants secondary to carboplatin treatment of the mother, it is recommended that breast-feeding be discontinued if the mother is treated with carboplatin injection. Pediatric Use Safety and effectiveness in pediatric patients have not been established (see WARNINGS: "audiologic toxicity"). Geriatric Use Of the 789 patients in initial treatment combination therapy studies (NCIC and SWOG), 395 patients were treated with carboplatin in combination with cyclophosphamide. Of these, 141 were over 65 years of age and 22 were 75 years or older. In these trials, age was not a prognostic factor for survival. In terms of safety, elderly patients treated with carboplatin were more likely to develop severe thrombocytopenia than younger patients. In a combined database of 1,942 patients (414 were ≥ 65 years of age) that received single agent carboplatin for different tumor types, a similar incidence of adverse events was seen in patients 65 years and older and in patients less than 65. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Because renal function is often decreased in the elderly, renal function should be considered in the selection of carboplatin injection dosage (see DOSAGE AND ADMINISTRATION ).
Warnings
openFDA Drug LabelingWARNINGS Bone marrow suppression (leukopenia, neutropenia, and thrombocytopenia) is dose-dependent and is also the dose-limiting toxicity. Peripheral blood counts should be frequently monitored during carboplatin treatment and, when appropriate, until recovery is achieved. Median nadir occurs at day 21 in patients receiving single agent carboplatin. In general, single intermittent courses of carboplatin should not be repeated until leukocyte, neutrophil, and platelet counts have recovered. Since anemia is cumulative, transfusions may be needed during treatment with carboplatin, particularly in patients receiving prolonged therapy. Bone marrow suppression is increased in patients who have received prior therapy, especially regimens including cisplatin. Marrow suppression is also increased in patients with impaired kidney function. Initial carboplatin dosages in these patients should be appropriately reduced (see DOSAGE AND ADMINISTRATION ) and blood counts should be carefully monitored between courses. The use of carboplatin in combination with other bone marrow suppressing therapies must be carefully managed with respect to dosage and timing in order to minimize additive effects. Hemolytic anemia with the presence of serologic drug-induced antibodies has been reported in patients treated with carboplatin. This event can be fatal. Hemolytic-uremic syndrome is a potentially life-threatening side effect. Carboplatin should be discontinued at the first sign of microangiopathic hemolytic anemia, such as rapidly falling hemoglobin with concomitant thrombocytopenia or elevation of serum bilirubin, serum creatinine, blood urea nitrogen, or lactate dehydrogenase (LDH). Renal failure may not be reversible with discontinuation of therapy and dialysis may be required (see ADVERSE REACTIONS ). Carboplatin has limited nephrotoxic potential, but concomitant treatment with aminoglycosides has resulted in increased renal and/or audiologic toxicity, and caution must be exercised when a patient receives both drugs. Clinically significant hearing loss has been reported to occur in pediatric patients when carboplatin was administered at higher than recommended doses in combination with other ototoxic agents. Delayed onset hearing loss has been reported in pediatric patients. Long-term audiometric follow‐up in this population is recommended. Carboplatin can induce emesis, which can be more severe in patients previously receiving emetogenic therapy. The incidence and intensity of emesis have been reduced by using premedication with antiemetics. Although no conclusive efficacy data exist with the following schedules of carboplatin, lengthening the duration of single intravenous administration to 24 hours or dividing the total dose over five consecutive daily pulse doses has resulted in reduced emesis. Although peripheral neurotoxicity is infrequent, its incidence is increased in patients older than 65 years and in patients previously treated with cisplatin. Pre-existing cisplatin-induced neurotoxicity does not worsen in about 70% of the patients receiving carboplatin as secondary treatment. Loss of vision, which can be complete for light and colors, has been reported after the use of carboplatin with doses higher than those recommended in the package insert. Vision appears to recover totally or to a significant extent within weeks of stopping these high doses. As in the case of other platinum-coordination compounds, allergic reactions to carboplatin have been reported. These may occur within minutes of administration and should be managed with appropriate supportive therapy. There is increased risk of allergic reactions including anaphylaxis in patients previously exposed to platinum therapy (see CONTRAINDICATIONS and ADVERSE REACTIONS: Allergic Reactions ). Hypersensitivity reactions which progressed to Kounis syndrome have also been reported (see ADVERSE REACTIONS: Allergic Reactions ). Patients at high risk of Tumor Lysis Syndrome (TLS), such as t …
Adverse Reactions
openFDA Drug LabelingADVERSE REACTIONS For a comparison of toxicities when carboplatin or cisplatin was given in combination with cyclophosphamide, see CLINICAL STUDIES: Use with Cyclophosphamide for Initial Treatment of Ovarian Cancer: Comparative Toxicity . ADVERSE EXPERIENCES IN PATIENTS WITH OVARIAN CANCER First Line Combination Therapy Use with Cyclophosphamide for Initial Treatment of Ovarian Cancer: Data are based on the experience of 393 patients with ovarian cancer (regardless of baseline status) who received initial combination therapy with carboplatin and cyclophosphamide in two randomized controlled studies conducted by SWOG and NCIC (see CLINICAL STUDIES ). Combination with cyclophosphamide as well as duration of treatment may be responsible for the differences that can be noted in the adverse experience table. Percent Second Line Single Agent Therapy Single Agent Use for the Secondary Treatment of Ovarian Cancer: Data are based on the experience of 553 patients with previously treated ovarian carcinoma (regardless of baseline status) who received single agent carboplatin. Percent Bone Marrow Thrombocytopenia <100,000/mm 3 66 62 <50,000/mm 3 33 35 Neutropenia <2,000 cells/mm 3 96 67 <1,000 cells/mm 3 82 21 Leukopenia <4,000 cells/mm 3 97 85 <2,000 cells/mm 3 71 26 Anemia <11 g/dL 90 90 <8 g/dL 14 21 Infections 16 5 Bleeding 8 5 Transfusions 35 44 Gastrointestinal Nausea and vomiting 93 92 Vomiting 83 81 Other GI side effects 46 21 Neurologic Peripheral neuropathies 15 6 Ototoxicity 12 1 Other sensory side effects 5 1 Central neurotoxicity 26 5 Renal Serum creatinine elevations 6 10 Blood urea elevations 17 22 Hepatic Bilirubin elevations 5 5 SGOT elevations 20 19 Alkaline phosphatase elevations 29 37 Electrolytes loss Sodium 10 47 Potassium 16 28 Calcium 16 31 Magnesium 61 43 Other side effects Pain 44 23 Asthenia 41 11 Cardiovascular 19 6 Respiratory 10 6 Allergic 11 2 Genitourinary 10 2 Alopecia 49 2 Mucositis 8 1 In the narrative section that follows, the incidences of adverse events are based on data from 1,893 patients with various types of tumors who received carboplatin as single agent therapy. Hematologic Toxicity Bone marrow suppression is the dose-limiting toxicity of carboplatin. Thrombocytopenia with platelet counts below 50,000/mm 3 occurs in 25% of the patients (35% of pretreated ovarian cancer patients); neutropenia with granulocyte counts below 1,000/mm 3 occurs in 16% of the patients (21% of pretreated ovarian cancer patients); leukopenia with WBC counts below 2,000/mm 3 occurs in 15% of the patients (26% of pretreated ovarian cancer patients). The nadir usually occurs about day 21 in patients receiving single agent therapy. By day 28, 90% of patients have platelet counts above 100,000/mm 3 ; 74% have neutrophil counts above 2,000/mm 3 ; 67% have leukocyte counts above 4,000/mm 3 . Marrow suppression is usually more severe in patients with impaired kidney function. Patients with poor performance status have also experienced a higher incidence of severe leukopenia and thrombocytopenia. The hematologic effects, although usually reversible, have resulted in infectious or hemorrhagic complications in 5% of the patients treated with carboplatin, with drug-related death occurring in less than 1% of the patients. Fever has also been reported in patients with neutropenia. Anemia with hemoglobin less than 11 g/dL has been observed in 71% of the patients who started therapy with a baseline above that value. The incidence of anemia increases with increasing exposure to carboplatin. Transfusions have been administered to 26% of the patients treated with carboplatin (44% of previously treated ovarian cancer patients). Bone marrow depression may be more severe when carboplatin is combined with other bone marrow suppressing drugs or with radiotherapy. Gastrointestinal Toxicity Vomiting occurs in 65% of the patients (81% of previously treated ovarian cancer patients) and in about one-third of these patients it is severe. Carboplatin, …
Drug Interactions
openFDA Drug LabelingDrug Interactions The renal effects of nephrotoxic compounds may be potentiated by carboplatin. A decrease in phenytoin serum levels has been observed with concurrent administration of carboplatin and phenytoin/fosphenytoin. This may lead to exacerbation of seizures.
Description
openFDA Drug LabelingDESCRIPTION Carboplatin Injection is supplied as a sterile, pyrogen-free, aqueous solution available in 50 mg/5 mL, 150 mg/15 mL, 450 mg/45 mL or 600 mg/60 mL multiple-dose vials containing 10 mg/mL of carboplatin for administration by intravenous infusion. Each mL contains 10 mg carboplatin and Water for Injection, USP. Carboplatin is a platinum coordination compound. The chemical name for carboplatin is platinum, diammine [1,1-cyclobutane-dicarboxylato(2-)-0,0']-,(SP-4-2), and carboplatin has the following structural formula: Carboplatin is a crystalline powder with the molecular formula of C 6 H 12 N 2 0 4 Pt and a molecular weight of 371.25. It is soluble in water at a rate of approximately 14 mg/mL, and the pH of a 1% solution is 5 to 7. It is virtually insoluble in ethanol, acetone, and dimethylacetamide. Chemical Structure
Overdosage
openFDA Drug LabelingOVERDOSAGE: There is no known antidote for Carboplatin Injection overdosage. The anticipated complications of overdosage would be secondary to bone marrow suppression and/or hepatic toxicity.
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED: Product No. NDC No. 107260 63323-172-60 CARBOplatin Injection, 600 mg per 60 mL (10 mg per mL), in a 60 mL multiple dose vial packaged individually. The container closure is not made with natural rubber latex. Storage Unopened vials of Carboplatin Injection are stable to the date indicated on the package when stored at 25°C (77°F); [excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Carboplatin Injection multidose vials maintain microbial, chemical, and physical stability for up to 14 days at 25°C following multiple needle entries. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Solutions for infusion should be discarded 8 hours after preparation. Handling and Disposal Caution should be exercised in handling and preparing carboplatin injection. Several guidelines on this subject have been published. 1-4 To minimize the risk of dermal exposure, always wear impervious gloves when handling vials containing carboplatin injection. If carboplatin injection contacts the skin, immediately wash the skin thoroughly with soap and water. If carboplatin injection contacts mucous membranes, the membranes should be flushed immediately and thoroughly with water. More information is available in the references listed below.
Storage Unopened vials of Carboplatin Injection are stable to the date indicated on the package when stored at 25°C (77°F); [excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Carboplatin Injection multidose vials maintain microbial, chemical, and physical stability for up to 14 days at 25°C following multiple needle entries. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Solutions for infusion should be discarded 8 hours after preparation.
Handling and Disposal Caution should be exercised in handling and preparing carboplatin injection. Several guidelines on this subject have been published. 1-4 To minimize the risk of dermal exposure, always wear impervious gloves when handling vials containing carboplatin injection. If carboplatin injection contacts the skin, immediately wash the skin thoroughly with soap and water. If carboplatin injection contacts mucous membranes, the membranes should be flushed immediately and thoroughly with water. More information is available in the references listed below.
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: CARBOPLATIN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Recalls
Source: FDA Enforcement| Classification | Reported | Firm | Reason | Status |
|---|---|---|---|---|
| Class I | February 13, 2013 | Hospira Inc. | Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals. | Completed |
| Class I | February 13, 2013 | Hospira Inc. | Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals. | Completed |
| Class II | September 26, 2012 | Hospira Inc. | The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are beig recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution. | Terminated |
| Class III | August 22, 2012 | Hospira Inc. | Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH. | Terminated |
Shortages
Source: FDA Drug Shortages| Status | Availability | Company | Presentation | Updated |
|---|---|---|---|---|
| Current | Available | Eugia US LLC | Carboplatin, Injection, 600 mg/60 mL (NDC 55150-386-01) | September 17, 2026 |
| Current | Unavailable | Eugia US LLC | Carboplatin, Injection, 450 mg/45 mL (NDC 55150-335-01) | September 17, 2026 |
| Current | Unavailable | Teyro Labs | Carboplatin, Injection, 150 mg/15 mL (10 mg/mL) Multiple Dose Vial (NDC 60505-6282-3) | September 16, 2026 |
| Current | Unavailable | Teyro Labs | Carboplatin, Injection, 450 mg/45 mL (10 mg/mL) Multiple Dose Vial (NDC 60505-6282-6) | September 16, 2026 |
| Current | Unavailable | Teyro Labs | Carboplatin, Injection, 600 mg/60 mL (10 mg/mL) Multiple Dose Vial (NDC 60505-6282-7) | September 16, 2026 |
| Current | Unavailable | Teyro Labs | Carboplatin, Injection, 50 mg/5 mL (10 mg/mL) Multiple Dose Vial (NDC 60505-6282-1) | September 16, 2026 |
| Current | Limited Availability | Gland Pharma Limited | Carboplatin, Injection, 600 mg/65 mL (NDC 54288-167-01) | September 15, 2026 |
| Current | Limited Availability | Teva Pharmaceuticals USA, Inc. | Carboplatin, Injection, 10 mg/1 mL (NDC 0703-4246-01) | September 15, 2026 |
| Current | Unavailable | Accord Healthcare Inc. | Carboplatin, Injection, 10 mg/1 mL (NDC 16729-295-33) | September 15, 2026 |
| Current | Unavailable | Accord Healthcare Inc. | Carboplatin, Injection, 10 mg/1 mL (NDC 16729-295-12) | September 15, 2026 |
| Current | Unavailable | Fresenius Kabi USA, LLC | Carboplatin, Injection, 10 mg/1 mL (NDC 63323-172-60) | September 15, 2026 |
| Current | Unavailable | Accord Healthcare Inc. | Carboplatin, Injection, 10 mg/1 mL (NDC 16729-295-34) | September 15, 2026 |
| Current | Available | Gland Pharma Limited | Carboplatin, Injection, 150mg/15mL (NDC 54288-165-01) | September 15, 2026 |
| Current | Limited Availability | Gland Pharma Limited | Carboplatin, Injection, 450mg/45mL (NDC 54288-166-01) | September 15, 2026 |
| Current | Limited Availability | Teva Pharmaceuticals USA, Inc. | Carboplatin, Injection, 10 mg/1 mL (NDC 0703-4239-01) | September 15, 2026 |
| Current | Limited Availability | Teva Pharmaceuticals USA, Inc. | Carboplatin, Injection, 10 mg/1 mL (NDC 0703-4248-01) | September 15, 2026 |
| Current | Unavailable | Gland Pharma Limited | Carboplatin, Injection, 50mg/5mL (NDC 54288-164-01) | September 15, 2026 |
| Current | Unavailable | Accord Healthcare Inc. | Carboplatin, Injection, 10 mg/1 mL (NDC 16729-295-31) | September 15, 2026 |
| Current | Unavailable | Teva Pharmaceuticals USA, Inc. | Carboplatin, Injection, 10 mg/1 mL (NDC 0703-4244-01) | September 15, 2026 |
| Current | Limited Availability | Hospira, Inc., a Pfizer Company | Carboplatin, Injection, 150 mg/15 mL (10 mg/mL) (NDC 61703-339-22) | September 9, 2026 |
| Current | Limited Availability | Hospira, Inc., a Pfizer Company | Carboplatin, Injection, 50 mg/5 mL (10 mg/mL) (NDC 61703-339-18) | September 9, 2026 |
| Current | Unavailable | Hospira, Inc., a Pfizer Company | Carboplatin, Injection, 450 mg/45 mL (10 mg/mL) (NDC 61703-262-05) | September 9, 2026 |
| Current | Limited Availability | Hospira, Inc., a Pfizer Company | Carboplatin, Injection, 450 mg/45 mL (10 mg/mL) (NDC 61703-339-50) | September 9, 2026 |
| Current | Unavailable | Hospira, Inc., a Pfizer Company | Carboplatin, Injection, 50 mg/5 mL (10 mg/mL) (NDC 61703-360-18) | September 9, 2026 |
| Current | Limited Availability | Hospira, Inc., a Pfizer Company | Carboplatin, Injection, 600 mg/60 mL (10 mg/mL) (NDC 61703-339-56) | September 9, 2026 |
| Current | Unavailable | Hospira, Inc., a Pfizer Company | Carboplatin, Injection, 600 mg/60 mL (10 mg/mL) (NDC 61703-600-05) | September 9, 2026 |
| Current | Unavailable | Hospira, Inc., a Pfizer Company | Carboplatin, Injection, 150 mg/15 mL (10 mg/mL) (NDC 61703-150-05) | September 9, 2026 |
| To Be Discontinued | Teyro Labs | Carboplatin, Injection, 50 mg/5 mL (10 mg/mL) Multiple Dose Vial (NDC 60505-6282-1) | June 1, 2026 | |
| To Be Discontinued | Teyro Labs | Carboplatin, Injection, 600 mg/60 mL (10 mg/mL) Multiple Dose Vial (NDC 60505-6282-7) | June 1, 2026 | |
| To Be Discontinued | Teyro Labs | Carboplatin, Injection, 450 mg/45 mL (10 mg/mL) Multiple Dose Vial (NDC 60505-6282-6) | June 1, 2026 | |
| To Be Discontinued | Teyro Labs | Carboplatin, Injection, 150 mg/15 mL (10 mg/mL) Multiple Dose Vial (NDC 60505-6282-3) | June 1, 2026 |
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 60505-6282-1 | 60505-6282 | Apotex Corp. | 1 VIAL, MULTI-DOSE in 1 CARTON (60505-6282-1) / 5 mL in 1 VIAL, MULTI-DOSE | January 10, 2024 |
| 60505-6282-3 | 60505-6282 | Apotex Corp. | 1 VIAL, MULTI-DOSE in 1 CARTON (60505-6282-3) / 15 mL in 1 VIAL, MULTI-DOSE | January 10, 2024 |
| 60505-6282-6 | 60505-6282 | Apotex Corp. | 1 VIAL, MULTI-DOSE in 1 CARTON (60505-6282-6) / 45 mL in 1 VIAL, MULTI-DOSE | January 10, 2024 |
| 60505-6282-7 | 60505-6282 | Apotex Corp. | 1 VIAL, MULTI-DOSE in 1 CARTON (60505-6282-7) / 60 mL in 1 VIAL, MULTI-DOSE | January 10, 2024 |
| 54288-164-01 | 54288-164 | BPI Labs LLC | 1 VIAL, MULTI-DOSE in 1 CARTON (54288-164-01) / 5 mL in 1 VIAL, MULTI-DOSE | July 31, 2023 |
| 54288-165-01 | 54288-165 | BPI Labs LLC | 1 VIAL, MULTI-DOSE in 1 CARTON (54288-165-01) / 15 mL in 1 VIAL, MULTI-DOSE | July 31, 2023 |
| 54288-166-01 | 54288-166 | BPI Labs LLC | 1 VIAL, MULTI-DOSE in 1 CARTON (54288-166-01) / 45 mL in 1 VIAL, MULTI-DOSE | July 31, 2023 |
| 54288-167-01 | 54288-167 | BPI Labs LLC | 1 VIAL, MULTI-DOSE in 1 CARTON (54288-167-01) / 60 mL in 1 VIAL, MULTI-DOSE | July 31, 2023 |
| 55150-333-01 | 55150-333 | Eugia US LLC | 1 VIAL, MULTI-DOSE in 1 CARTON (55150-333-01) / 5 mL in 1 VIAL, MULTI-DOSE | September 29, 2016 |
| 55150-334-01 | 55150-334 | Eugia US LLC | 1 VIAL, MULTI-DOSE in 1 CARTON (55150-334-01) / 15 mL in 1 VIAL, MULTI-DOSE | September 29, 2016 |
| 55150-335-00 | 55150-335 | Eugia US LLC | 1 VIAL, MULTI-DOSE in 1 CARTON (55150-335-00) / 45 mL in 1 VIAL, MULTI-DOSE | September 29, 2016 |
| 55150-335-01 | 55150-335 | Eugia US LLC | 1 VIAL, MULTI-DOSE in 1 CARTON (55150-335-01) / 45 mL in 1 VIAL, MULTI-DOSE | September 29, 2016 |
| 55150-386-00 | 55150-386 | Eugia US LLC | 1 VIAL, MULTI-DOSE in 1 CARTON (55150-386-00) / 60 mL in 1 VIAL, MULTI-DOSE | August 3, 2020 |
| 55150-386-01 | 55150-386 | Eugia US LLC | 1 VIAL, MULTI-DOSE in 1 CARTON (55150-386-01) / 60 mL in 1 VIAL, MULTI-DOSE | August 3, 2020 |
| 63323-172-60 | 63323-172 | Fresenius Kabi USA, LLC | 1 VIAL in 1 BOX (63323-172-60) / 60 mL in 1 VIAL | December 11, 2009 |
| 68083-190-01 | 68083-190 | Gland Pharma Limited | 1 VIAL, MULTI-DOSE in 1 CARTON (68083-190-01) / 5 mL in 1 VIAL, MULTI-DOSE | February 20, 2017 |
| 68083-191-01 | 68083-191 | Gland Pharma Limited | 1 VIAL, MULTI-DOSE in 1 CARTON (68083-191-01) / 15 mL in 1 VIAL, MULTI-DOSE | February 20, 2017 |
| 68083-192-01 | 68083-192 | Gland Pharma Limited | 1 VIAL, MULTI-DOSE in 1 CARTON (68083-192-01) / 45 mL in 1 VIAL, MULTI-DOSE | February 20, 2017 |
| 68083-193-01 | 68083-193 | Gland Pharma Limited | 1 VIAL, MULTI-DOSE in 1 CARTON (68083-193-01) / 60 mL in 1 VIAL, MULTI-DOSE | February 20, 2017 |
| 61703-150-05 | 61703-150 | Hospira, Inc. | 1 VIAL, MULTI-DOSE in 1 CARTON (61703-150-05) / 15 mL in 1 VIAL, MULTI-DOSE | May 23, 2022 |
| 61703-262-05 | 61703-262 | Hospira, Inc. | 1 VIAL, MULTI-DOSE in 1 CARTON (61703-262-05) / 45 mL in 1 VIAL, MULTI-DOSE | May 23, 2022 |
| 61703-339-18 | 61703-339 | Hospira, Inc. | 1 VIAL, MULTI-DOSE in 1 CARTON (61703-339-18) / 5 mL in 1 VIAL, MULTI-DOSE | October 14, 2004 |
| 61703-339-22 | 61703-339 | Hospira, Inc. | 1 VIAL, MULTI-DOSE in 1 CARTON (61703-339-22) / 15 mL in 1 VIAL, MULTI-DOSE | October 14, 2004 |
| 61703-339-50 | 61703-339 | Hospira, Inc. | 1 VIAL, MULTI-DOSE in 1 CARTON (61703-339-50) / 45 mL in 1 VIAL, MULTI-DOSE | October 14, 2004 |
| 61703-339-56 | 61703-339 | Hospira, Inc. | 1 VIAL, MULTI-DOSE in 1 CARTON (61703-339-56) / 60 mL in 1 VIAL, MULTI-DOSE | November 23, 2004 |
| 61703-360-18 | 61703-360 | Hospira, Inc. | 1 VIAL, MULTI-DOSE in 1 CARTON (61703-360-18) / 5 mL in 1 VIAL, MULTI-DOSE | May 23, 2022 |
| 61703-600-05 | 61703-600 | Hospira, Inc. | 1 VIAL, MULTI-DOSE in 1 CARTON (61703-600-05) / 60 mL in 1 VIAL, MULTI-DOSE | May 23, 2022 |
| 69339-364-05 | 69339-364 | Natco Pharma USA LLC | 1 VIAL, MULTI-DOSE in 1 CARTON (69339-364-05) / 5 mL in 1 VIAL, MULTI-DOSE | July 2, 2026 |
| 69339-365-15 | 69339-365 | Natco Pharma USA LLC | 1 VIAL, MULTI-DOSE in 1 CARTON (69339-365-15) / 15 mL in 1 VIAL, MULTI-DOSE | July 2, 2026 |
| 69339-366-45 | 69339-366 | Natco Pharma USA LLC | 1 VIAL, MULTI-DOSE in 1 CARTON (69339-366-45) / 45 mL in 1 VIAL, MULTI-DOSE | July 2, 2026 |
| 69339-367-60 | 69339-367 | Natco Pharma USA LLC | 1 VIAL, MULTI-DOSE in 1 CARTON (69339-367-60) / 60 mL in 1 VIAL, MULTI-DOSE | July 2, 2026 |
| 0703-4239-01 | 0703-4239 | Teva Parenteral Medicines, Inc. | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-4239-01) / 60 mL in 1 VIAL, MULTI-DOSE | October 23, 2014 |
| 0703-4239-81 | 0703-4239 | Teva Parenteral Medicines, Inc. | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-4239-81) / 60 mL in 1 VIAL, MULTI-DOSE | January 19, 2016 |
| 0703-4244-01 | 0703-4244 | Teva Parenteral Medicines, Inc. | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-4244-01) / 5 mL in 1 VIAL, MULTI-DOSE | May 4, 2006 |
| 0703-4244-81 | 0703-4244 | Teva Parenteral Medicines, Inc. | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-4244-81) / 5 mL in 1 VIAL, MULTI-DOSE | January 15, 2016 |
| 0703-4246-01 | 0703-4246 | Teva Parenteral Medicines, Inc. | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-4246-01) / 15 mL in 1 VIAL, MULTI-DOSE | May 1, 2006 |
| 0703-4246-81 | 0703-4246 | Teva Parenteral Medicines, Inc. | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-4246-81) / 15 mL in 1 VIAL, MULTI-DOSE | November 25, 2015 |
| 0703-4248-01 | 0703-4248 | Teva Parenteral Medicines, Inc. | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-4248-01) / 45 mL in 1 VIAL, MULTI-DOSE | February 1, 2006 |
| 0703-4248-81 | 0703-4248 | Teva Parenteral Medicines, Inc. | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-4248-81) / 45 mL in 1 VIAL, MULTI-DOSE | December 9, 2015 |
| 82511-003-05 | 82511-003 | Teyro Labs Private Limited | 1 VIAL, MULTI-DOSE in 1 CARTON (82511-003-05) / 5 mL in 1 VIAL, MULTI-DOSE | January 18, 2007 |
| 82511-004-15 | 82511-004 | Teyro Labs Private Limited | 1 VIAL, MULTI-DOSE in 1 CARTON (82511-004-15) / 15 mL in 1 VIAL, MULTI-DOSE | January 18, 2007 |
| 82511-005-45 | 82511-005 | Teyro Labs Private Limited | 1 VIAL, MULTI-DOSE in 1 CARTON (82511-005-45) / 45 mL in 1 VIAL, MULTI-DOSE | January 18, 2007 |
| 82511-006-60 | 82511-006 | Teyro Labs Private Limited | 1 VIAL, MULTI-DOSE in 1 CARTON (82511-006-60) / 60 mL in 1 VIAL, MULTI-DOSE | August 24, 2023 |
| 60505-6282 | 60505-6282 | Apotex Corp. | — | January 18, 2007 |
| 54288-164 | 54288-164 | BPI Labs LLC | — | July 31, 2023 |
| 54288-165 | 54288-165 | BPI Labs LLC | — | July 31, 2023 |
| 54288-166 | 54288-166 | BPI Labs LLC | — | July 31, 2023 |
| 54288-167 | 54288-167 | BPI Labs LLC | — | July 31, 2023 |
| 55150-333 | 55150-333 | Eugia US LLC | — | September 29, 2016 |
| 55150-334 | 55150-334 | Eugia US LLC | — | September 29, 2016 |
| 55150-335 | 55150-335 | Eugia US LLC | — | September 29, 2016 |
| 55150-386 | 55150-386 | Eugia US LLC | — | August 3, 2020 |
| 63323-172 | 63323-172 | Fresenius Kabi USA, LLC | — | December 11, 2009 |
| 68083-190 | 68083-190 | Gland Pharma Limited | — | February 20, 2017 |
| 68083-191 | 68083-191 | Gland Pharma Limited | — | February 20, 2017 |
| 68083-192 | 68083-192 | Gland Pharma Limited | — | February 20, 2017 |
| 68083-193 | 68083-193 | Gland Pharma Limited | — | February 20, 2017 |
| 61703-150 | 61703-150 | Hospira, Inc. | — | May 23, 2022 |
| 61703-262 | 61703-262 | Hospira, Inc. | — | May 23, 2022 |
| 61703-339 | 61703-339 | Hospira, Inc. | — | October 14, 2004 |
| 61703-360 | 61703-360 | Hospira, Inc. | — | May 23, 2022 |
| 61703-600 | 61703-600 | Hospira, Inc. | — | May 23, 2022 |
| 69339-364 | 69339-364 | Natco Pharma USA LLC | — | July 2, 2026 |
| 69339-365 | 69339-365 | Natco Pharma USA LLC | — | July 2, 2026 |
| 69339-366 | 69339-366 | Natco Pharma USA LLC | — | July 2, 2026 |
| 69339-367 | 69339-367 | Natco Pharma USA LLC | — | July 2, 2026 |
| 0703-4239 | 0703-4239 | Teva Parenteral Medicines, Inc. | — | October 23, 2014 |
| 0703-4244 | 0703-4244 | Teva Parenteral Medicines, Inc. | — | January 15, 2016 |
| 0703-4246 | 0703-4246 | Teva Parenteral Medicines, Inc. | — | November 25, 2015 |
| 0703-4248 | 0703-4248 | Teva Parenteral Medicines, Inc. | — | December 9, 2015 |
| 82511-003 | 82511-003 | Teyro Labs Private Limited | — | January 18, 2007 |
| 82511-004 | 82511-004 | Teyro Labs Private Limited | — | January 18, 2007 |
| 82511-005 | 82511-005 | Teyro Labs Private Limited | — | January 18, 2007 |
| 82511-006 | 82511-006 | Teyro Labs Private Limited | — | August 24, 2023 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
| Enforcement | FDA | Recall records |
| Drug Shortages | FDA | Supply availability |
Generated September 25, 2026 · 13 sections on this page.