carboplatin

Generic: carboplatin

Labeler: bpi labs llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carboplatin
Generic Name carboplatin
Labeler bpi labs llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

carboplatin 10 mg/mL

Manufacturer
BPI Labs LLC

Identifiers & Regulatory

Product NDC 54288-167
Product ID 54288-167_c0a7463c-d90f-4060-a54e-6a4888e8af0e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207324
Listing Expiration 2026-12-31
Marketing Start 2023-07-31

Pharmacologic Class

Established (EPC)
platinum-based drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54288167
Hyphenated Format 54288-167

Supplemental Identifiers

RxCUI
597195
UPC
0354288167017 0354288164016 0354288165013 0354288166010
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 ANDA207324 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (54288-167-01) / 60 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

54288-167-01 1 VIAL, MULTI-DOSE in 1 CARTON (54288-167-01) / 60 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

carboplatin (10 mg/mL)

Linked Drug Pages (1)

CARBOPLATIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "c0a7463c-d90f-4060-a54e-6a4888e8af0e", "openfda": {"nui": ["N0000175413", "N0000175073"], "upc": ["0354288167017", "0354288164016", "0354288165013", "0354288166010"], "unii": ["BG3F62OND5"], "rxcui": ["597195"], "spl_set_id": ["5484d2f0-0cc2-4bba-8f26-c7f6539a9606"], "pharm_class_epc": ["Platinum-based Drug [EPC]"], "manufacturer_name": ["BPI Labs LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (54288-167-01)  / 60 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "54288-167-01", "marketing_start_date": "20230731"}], "brand_name": "CARBOPLATIN", "product_id": "54288-167_c0a7463c-d90f-4060-a54e-6a4888e8af0e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Platinum-based Drug [EPC]", "Platinum-containing Compounds [EXT]"], "product_ndc": "54288-167", "generic_name": "Carboplatin", "labeler_name": "BPI Labs LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CARBOPLATIN", "active_ingredients": [{"name": "CARBOPLATIN", "strength": "10 mg/mL"}], "application_number": "ANDA207324", "marketing_category": "ANDA", "marketing_start_date": "20230731", "listing_expiration_date": "20261231"}