etoposide

Generic: etoposide

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

Drug Facts

Product Profile

Brand Name etoposide
Generic Name etoposide
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

etoposide 20 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-176
Product ID 71288-176_737a9d5b-1260-408a-a117-b0b3aeba6ad4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074529
Listing Expiration 2026-12-31
Marketing Start 2025-02-01

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 71288176
Hyphenated Format 71288-176

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 ANDA074529 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (71288-176-25) / 25 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

71288-176-25 1 VIAL, MULTI-DOSE in 1 CARTON (71288-176-25) / 25 mL in 1 VIAL, MULTI-DOSE

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": "737a9d5b-1260-408a-a117-b0b3aeba6ad4", "openfda": {"nui": ["N0000175609", "N0000000176"], "unii": ["6PLQ3CP4P3"], "rxcui": ["310248"], "spl_set_id": ["50491106-dddd-4efd-bd83-060e7947a244"], "pharm_class_epc": ["Topoisomerase Inhibitor [EPC]"], "pharm_class_moa": ["Topoisomerase Inhibitors [MoA]"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (71288-176-25)  / 25 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "71288-176-25", "marketing_start_date": "20250201"}], "brand_name": "Etoposide", "product_id": "71288-176_737a9d5b-1260-408a-a117-b0b3aeba6ad4", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "71288-176", "generic_name": "Etoposide", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Etoposide", "active_ingredients": [{"name": "ETOPOSIDE", "strength": "20 mg/mL"}], "application_number": "ANDA074529", "marketing_category": "ANDA", "marketing_start_date": "20250201", "listing_expiration_date": "20261231"}