carboplatin

Generic: carboplatin

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carboplatin
Generic Name carboplatin
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

carboplatin 10 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-191
Product ID 68083-191_5af07c55-5bef-4da3-91fa-9b3d8d1253d3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207324
Listing Expiration 2026-12-31
Marketing Start 2017-02-20

Pharmacologic Class

Established (EPC)
platinum-based drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083191
Hyphenated Format 68083-191

Supplemental Identifiers

RxCUI
597195
UPC
0368083192013 0368083193010 0368083191016
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 (68083-191-01) / 15 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

68083-191-01 1 VIAL, MULTI-DOSE in 1 CARTON (68083-191-01) / 15 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": "5af07c55-5bef-4da3-91fa-9b3d8d1253d3", "openfda": {"nui": ["N0000175413", "N0000175073"], "upc": ["0368083192013", "0368083193010", "0368083191016"], "unii": ["BG3F62OND5"], "rxcui": ["597195"], "spl_set_id": ["9eb057eb-29ce-40d2-9ac8-ed107f25f5ab"], "pharm_class_epc": ["Platinum-based Drug [EPC]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (68083-191-01)  / 15 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "68083-191-01", "marketing_start_date": "20170220"}], "brand_name": "CARBOPLATIN", "product_id": "68083-191_5af07c55-5bef-4da3-91fa-9b3d8d1253d3", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Platinum-based Drug [EPC]", "Platinum-containing Compounds [EXT]"], "product_ndc": "68083-191", "generic_name": "Carboplatin", "labeler_name": "Gland Pharma Limited", "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": "20170220", "listing_expiration_date": "20261231"}