carboplatin

Generic: carboplatin

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carboplatin
Generic Name carboplatin
Labeler eugia us llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

carboplatin 600 mg/60mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-386
Product ID 55150-386_5abfcb87-bb02-4384-9c9d-7d0e3e809311
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205487
Listing Expiration 2026-12-31
Marketing Start 2020-08-03

Pharmacologic Class

Established (EPC)
platinum-based drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150386
Hyphenated Format 55150-386

Supplemental Identifiers

RxCUI
597195
UNII
BG3F62OND5
NUI
N0000175413 N0000175073

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name carboplatin (source: ndc)
Generic Name carboplatin (source: ndc)
Application Number ANDA205487 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 600 mg/60mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (55150-386-00) / 60 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

55150-386-00 1 VIAL, MULTI-DOSE in 1 CARTON (55150-386-00) / 60 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

carboplatin (600 mg/60mL)

Linked Drug Pages (2)

CARBOPLATIN ndc-match (0.9) CARBOPLATIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "5abfcb87-bb02-4384-9c9d-7d0e3e809311", "openfda": {"nui": ["N0000175413", "N0000175073"], "unii": ["BG3F62OND5"], "rxcui": ["597195"], "spl_set_id": ["5abfcb87-bb02-4384-9c9d-7d0e3e809311"], "pharm_class_epc": ["Platinum-based Drug [EPC]"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (55150-386-00)  / 60 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "55150-386-00", "marketing_start_date": "20200803"}], "brand_name": "CARBOPLATIN", "product_id": "55150-386_5abfcb87-bb02-4384-9c9d-7d0e3e809311", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Platinum-based Drug [EPC]", "Platinum-containing Compounds [EXT]"], "product_ndc": "55150-386", "generic_name": "CARBOPLATIN", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CARBOPLATIN", "active_ingredients": [{"name": "CARBOPLATIN", "strength": "600 mg/60mL"}], "application_number": "ANDA205487", "marketing_category": "ANDA", "marketing_start_date": "20200803", "listing_expiration_date": "20261231"}