etoposide

Generic: etoposide

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name etoposide
Generic Name etoposide
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

etoposide 20 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-104
Product ID 63323-104_d672a555-bb0e-4a82-ac5e-5c9393b59c28
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074983
Listing Expiration 2026-12-31
Marketing Start 2001-07-18

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 63323104
Hyphenated Format 63323-104

Supplemental Identifiers

RxCUI
310248
UPC
0363323104016 0363323104252 0363323104061 0363323104504
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 ANDA074983 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 10 BOX in 1 CARTON (63323-104-05) / 1 VIAL, MULTI-DOSE in 1 BOX (63323-104-01) / 5 mL in 1 VIAL, MULTI-DOSE
  • 1 VIAL, MULTI-DOSE in 1 CARTON (63323-104-06) / 5 mL in 1 VIAL, MULTI-DOSE
  • 1 VIAL, MULTI-DOSE in 1 CARTON (63323-104-25) / 25 mL in 1 VIAL, MULTI-DOSE
  • 1 VIAL, MULTI-DOSE in 1 CARTON (63323-104-50) / 50 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (4)

63323-104-05 10 BOX in 1 CARTON (63323-104-05) / 1 VIAL, MULTI-DOSE in 1 BOX (63323-104-01) / 5 mL in 1 VIAL, MULTI-DOSE 63323-104-06 1 VIAL, MULTI-DOSE in 1 CARTON (63323-104-06) / 5 mL in 1 VIAL, MULTI-DOSE 63323-104-25 1 VIAL, MULTI-DOSE in 1 CARTON (63323-104-25) / 25 mL in 1 VIAL, MULTI-DOSE 63323-104-50 1 VIAL, MULTI-DOSE in 1 CARTON (63323-104-50) / 50 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": "d672a555-bb0e-4a82-ac5e-5c9393b59c28", "openfda": {"nui": ["N0000175609", "N0000000176"], "upc": ["0363323104016", "0363323104252", "0363323104061", "0363323104504"], "unii": ["6PLQ3CP4P3"], "rxcui": ["310248"], "spl_set_id": ["fe870629-104d-4d67-a7c6-f53bc588121e"], "pharm_class_epc": ["Topoisomerase Inhibitor [EPC]"], "pharm_class_moa": ["Topoisomerase Inhibitors [MoA]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BOX in 1 CARTON (63323-104-05)  / 1 VIAL, MULTI-DOSE in 1 BOX (63323-104-01)  / 5 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "63323-104-05", "marketing_start_date": "20010718"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (63323-104-06)  / 5 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "63323-104-06", "marketing_start_date": "20220909"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (63323-104-25)  / 25 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "63323-104-25", "marketing_start_date": "20010718"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (63323-104-50)  / 50 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "63323-104-50", "marketing_start_date": "20010718"}], "brand_name": "Etoposide", "product_id": "63323-104_d672a555-bb0e-4a82-ac5e-5c9393b59c28", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "63323-104", "generic_name": "ETOPOSIDE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Etoposide", "active_ingredients": [{"name": "ETOPOSIDE", "strength": "20 mg/mL"}], "application_number": "ANDA074983", "marketing_category": "ANDA", "marketing_start_date": "20010718", "listing_expiration_date": "20261231"}