Home NDC 61269-410 ETOPOPHOS
Product NDC 61269-410
11-digit product format 612690410
Labeler code 61269
Product ID 61269-410_656f0cdd-f6bf-444d-ade9-f1703a31da58
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name etoposide phosphate
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler H2-Pharma, LLC
Application NDA020457
Marketing category NDA
Marketing start 2009-06-01
Substance ETOPOSIDE PHOSPHATE
Active strength 100 mg/1
Pharmacologic classes Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61269-410-20 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61269-410-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61269-410-20 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020457-001 ETOPOPHOS PRESERVATIVE FREE ETOPOSIDE PHOSPHATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020457-001 ETOPOPHOS PRESERVATIVE FREE EQ 100MG BASE/VIAL INJECTABLE / INJECTION RLD, RS 1996-05-17 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base ETOPOPHOS
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ETOPOSIDE PHOSPHATE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 528XYJ8L1N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 226719 Internal RxNorm lookup 1734340 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61269-410-20 ETOPOPHOS 1 in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 22 61269-410-20 ETOPOPHOS 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 22
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61269-410 ETOPOPHOS (ETOPOSIDE PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [H2-PHARMA, LLC] 21 Current NDC, Legacy NDC, 2 package rows 20250202_7499fc35-fae8-44ad-bbab-9a1a589bf3ee.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 61269-410-20 61269041020 1 VIAL, SINGLE-DOSE in 1 CARTON (61269-410-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2009-06-01 0000-00-00 No No Current