Home NDC 0015-3404-20 ETOPOPHOS
Product NDC 0015-3404
Requested package NDC 0015-3404-20
11-digit product format 000153404
Labeler code 0015
Product ID 0015-3404_f781e9d9-650f-4d32-b78c-0660a0ea743a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name etoposide phosphate
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler E.R. Squibb & Sons, L.L.C.
Application NDA020457
Marketing category NDA
Marketing start 2009-06-01
Marketing end 2021-04-30
Substance ETOPOSIDE PHOSPHATE
Active strength 100 mg/1
Pharmacologic classes Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded etoposide phosphate ACTIVE INGREDIENT 528XYJ8L1N ETOPOPHOS (ETOPOSIDE PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 7 etoposide ACTIVE MOIETY 6PLQ3CP4P3 ETOPOPHOS (ETOPOSIDE PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 7 dextran 40 INACTIVE INGREDIENT K3R6ZDH4DU ETOPOPHOS (ETOPOSIDE PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 7 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR ETOPOPHOS (ETOPOSIDE PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 7
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ETOPOPHOS ETOPOSIDE PHOSPHATE H2-Pharma, LLC 7499fc35-fae8-44ad-bbab-9a1a589bf3ee 2025-11-25 Warnings, Adverse reactions Exact identifier application applno (NDA): 020457 application number: NDA020457
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0015-3404-20 00015340420 1 VIAL, SINGLE-DOSE in 1 CARTON (0015-3404-20) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2009-06-01 2021-04-30 No No Current