etopophos

Generic: etoposide phosphate

Labeler: h2-pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name etopophos
Generic Name etoposide phosphate
Labeler h2-pharma, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

etoposide phosphate 100 mg/1

Manufacturer
H2-Pharma, LLC

Identifiers & Regulatory

Product NDC 61269-410
Product ID 61269-410_656f0cdd-f6bf-444d-ade9-f1703a31da58
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020457
Listing Expiration 2026-12-31
Marketing Start 2009-06-01

Pharmacologic Class

Classes
topoisomerase inhibitor [epc] topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61269410
Hyphenated Format 61269-410

Supplemental Identifiers

RxCUI
226719 1734340
UNII
528XYJ8L1N

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 etopophos (source: ndc)
Generic Name etoposide phosphate (source: ndc)
Application Number NDA020457 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (61269-410-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

Ingredients (1)

etoposide phosphate (100 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "656f0cdd-f6bf-444d-ade9-f1703a31da58", "openfda": {"unii": ["528XYJ8L1N"], "rxcui": ["226719", "1734340"], "spl_set_id": ["7499fc35-fae8-44ad-bbab-9a1a589bf3ee"], "manufacturer_name": ["H2-Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (61269-410-20)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE", "package_ndc": "61269-410-20", "marketing_start_date": "20090601"}], "brand_name": "ETOPOPHOS", "product_id": "61269-410_656f0cdd-f6bf-444d-ade9-f1703a31da58", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "61269-410", "generic_name": "etoposide phosphate", "labeler_name": "H2-Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ETOPOPHOS", "active_ingredients": [{"name": "ETOPOSIDE PHOSPHATE", "strength": "100 mg/1"}], "application_number": "NDA020457", "marketing_category": "NDA", "marketing_start_date": "20090601", "listing_expiration_date": "20261231"}