Home NDC 16729-262-31 Etoposide
Product NDC 16729-262
Requested package NDC 16729-262-31
11-digit product format 167290262
Labeler code 16729
Product ID 16729-262_bb6eeb29-d900-21f6-e053-2a95a90a679e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Etoposide
Dosage form INJECTION
Route INTRAVENOUS
Labeler Accord Healthcare Inc.
Application ANDA074513
Marketing category ANDA
Marketing start 2013-08-22
Marketing end 2021-10-31
Substance ETOPOSIDE
Active strength 20 mg/mL
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 42 .
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 A074513-001 ETOPOSIDE ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074513-001 AP
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 · 42 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 2026-08-18 06:07:40 2026-07 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074513-001 ETOPOSIDE 20MG/ML INJECTABLE / INJECTION AP 1996-03-14 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Socrata Ingredients# 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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 16729-262-31 16729026231 1 VIAL, MULTI-DOSE in 1 BOX (16729-262-31) > 5 mL in 1 VIAL, MULTI-DOSE 2013-08-22 2021-10-31 No No Current