etoposide

Generic: etoposide

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name etoposide
Generic Name etoposide
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

etoposide 20 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9512
Product ID 0143-9512_15cf77cf-4207-463d-b6ef-16163db5afb9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074290
Listing Expiration 2026-12-31
Marketing Start 1997-02-01

Pharmacologic Class

Established (EPC)
topoisomerase inhibitor [epc]
Mechanism of Action
topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439512
Hyphenated Format 0143-9512

Supplemental Identifiers

RxCUI
310248
UNII
6PLQ3CP4P3
NUI
N0000175609 N0000000176

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 etoposide (source: ndc)
Generic Name etoposide (source: ndc)
Application Number ANDA074290 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 BOX, UNIT-DOSE (0143-9512-01) / 50 mL in 1 VIAL
source: ndc

Packages (1)

0143-9512-01 1 VIAL in 1 BOX, UNIT-DOSE (0143-9512-01) / 50 mL in 1 VIAL

Ingredients (1)

etoposide (20 mg/mL)

Linked Drug Pages (1)

Etoposide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "15cf77cf-4207-463d-b6ef-16163db5afb9", "openfda": {"nui": ["N0000175609", "N0000000176"], "unii": ["6PLQ3CP4P3"], "rxcui": ["310248"], "spl_set_id": ["6dfedeff-a807-4405-a482-2f7109ad31c9"], "pharm_class_epc": ["Topoisomerase Inhibitor [EPC]"], "pharm_class_moa": ["Topoisomerase Inhibitors [MoA]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BOX, UNIT-DOSE (0143-9512-01)  / 50 mL in 1 VIAL", "package_ndc": "0143-9512-01", "marketing_start_date": "20171023"}], "brand_name": "Etoposide", "product_id": "0143-9512_15cf77cf-4207-463d-b6ef-16163db5afb9", "dosage_form": "INJECTION", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "0143-9512", "generic_name": "Etoposide", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Etoposide", "active_ingredients": [{"name": "ETOPOSIDE", "strength": "20 mg/mL"}], "application_number": "ANDA074290", "marketing_category": "ANDA", "marketing_start_date": "19970201", "listing_expiration_date": "20261231"}