carboplatin

Generic: carboplatin

Labeler: accord healthcare, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carboplatin
Generic Name carboplatin
Labeler accord healthcare, inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

carboplatin 10 mg/mL

Manufacturer
Accord Healthcare, Inc.

Identifiers & Regulatory

Product NDC 16729-295
Product ID 16729-295_35cf6068-f31a-211b-e063-6294a90a6b53
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206775
Listing Expiration 2026-12-31
Marketing Start 2017-09-19

Pharmacologic Class

Established (EPC)
platinum-based drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729295
Hyphenated Format 16729-295

Supplemental Identifiers

RxCUI
597195
UPC
0316729295345 0316729295383 0316729295338 0316729295123 0316729295314
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 ANDA206775 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (16729-295-12) / 60 mL in 1 VIAL, MULTI-DOSE
  • 1 VIAL, MULTI-DOSE in 1 CARTON (16729-295-31) / 5 mL in 1 VIAL, MULTI-DOSE
  • 1 VIAL, MULTI-DOSE in 1 CARTON (16729-295-33) / 15 mL in 1 VIAL, MULTI-DOSE
  • 1 VIAL, MULTI-DOSE in 1 CARTON (16729-295-34) / 45 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (4)

16729-295-12 1 VIAL, MULTI-DOSE in 1 CARTON (16729-295-12) / 60 mL in 1 VIAL, MULTI-DOSE 16729-295-31 1 VIAL, MULTI-DOSE in 1 CARTON (16729-295-31) / 5 mL in 1 VIAL, MULTI-DOSE 16729-295-33 1 VIAL, MULTI-DOSE in 1 CARTON (16729-295-33) / 15 mL in 1 VIAL, MULTI-DOSE 16729-295-34 1 VIAL, MULTI-DOSE in 1 CARTON (16729-295-34) / 45 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": "35cf6068-f31a-211b-e063-6294a90a6b53", "openfda": {"nui": ["N0000175413", "N0000175073"], "upc": ["0316729295345", "0316729295383", "0316729295338", "0316729295123", "0316729295314"], "unii": ["BG3F62OND5"], "rxcui": ["597195"], "spl_set_id": ["48aa7ef3-9f44-2a08-e054-00144ff88e88"], "pharm_class_epc": ["Platinum-based Drug [EPC]"], "manufacturer_name": ["Accord Healthcare, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (16729-295-12)  / 60 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "16729-295-12", "marketing_start_date": "20171003"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (16729-295-31)  / 5 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "16729-295-31", "marketing_start_date": "20170919"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (16729-295-33)  / 15 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "16729-295-33", "marketing_start_date": "20170919"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (16729-295-34)  / 45 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "16729-295-34", "marketing_start_date": "20170919"}], "brand_name": "Carboplatin", "product_id": "16729-295_35cf6068-f31a-211b-e063-6294a90a6b53", "dosage_form": "INJECTION", "pharm_class": ["Platinum-based Drug [EPC]", "Platinum-containing Compounds [EXT]"], "product_ndc": "16729-295", "generic_name": "Carboplatin", "labeler_name": "Accord Healthcare, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carboplatin", "active_ingredients": [{"name": "CARBOPLATIN", "strength": "10 mg/mL"}], "application_number": "ANDA206775", "marketing_category": "ANDA", "marketing_start_date": "20170919", "listing_expiration_date": "20261231"}