Home NDC 0378-3266 Etoposide
Product NDC 0378-3266
11-digit product format 003783266
Labeler code 0378
Product ID 0378-3266_a591eea6-af04-4207-b0f7-61fbada4719c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name etoposide
Dosage form CAPSULE
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA075635
Marketing category ANDA
Marketing start 2001-10-22
Substance ETOPOSIDE
Active strength 50 mg/1
Pharmacologic classes Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 A075635-001 ETOPOSIDE ETOPOSIDE 50MG CAPSULE / ORAL AB RS 2001-09-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075635-001 AB
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 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL AB RS 2001-09-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL AB RS 2001-09-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075635-001 ETOPOSIDE 50MG CAPSULE / ORAL RS 2001-09-19 e64feba35796…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 A075635-001 AB 1 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075635-001 AB 1 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A075635-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Etoposide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ETOPOSIDE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6PLQ3CP4P3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197687 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0378-3266-94 Etoposide 20 in 1 CARTON CAPSULE 20 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-3266 ETOPOSIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 9 Current NDC, Legacy NDC, 1 package rows 20181019_508a418e-985f-4208-9324-2230655bb5c2.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 Units Marketing start Marketing end Sample Exclude flag Status 0378-3266-94 00378326694 20 CAPSULE in 1 CARTON (0378-3266-94) 20 capsule 2001-10-22 0000-00-00 No No Current