Home NDC 83270-451 ETOPOSIDE
Product NDC 83270-451
11-digit product format 832700451
Labeler code 83270
Product ID 83270-451_5744cb93-0a8c-19ca-e063-6294a90aecd6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ETOPOSIDE
Dosage form CAPSULE
Route ORAL
Labeler Onesource Specialty Pharma Limited
Application NDA019557
Marketing category NDA
Marketing start 2026-05-29
Substance ETOPOSIDE
Active strength 50 mg/1
Pharmacologic classes Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019557-001 VEPESID ETOPOSIDE 50MG CAPSULE / ORAL AB RLD 1986-12-30 N019557-002 VEPESID ETOPOSIDE 100MG CAPSULE / ORAL RLD 1986-12-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019557-001 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 3 · 86 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 2026-09-14 22:38:34 2026-08 N019557-001 VEPESID 50MG CAPSULE / ORAL AB RLD 1986-12-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019557-001 VEPESID 50MG CAPSULE / ORAL AB RLD 1986-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019557-001 VEPESID 50MG CAPSULE / ORAL AB RLD 1986-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019557-001 VEPESID 50MG CAPSULE / ORAL RLD 1986-12-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019557-002 VEPESID 100MG CAPSULE / ORAL RLD 1986-12-30 74a2ff9319b5…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base ETOPOSIDE
Listing expiration 2027-12-31 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 83270-451-05 ETOPOSIDE 20 in 1 CARTON CAPSULE 20 1
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83270-451-05 83270045105 20 CAPSULE in 1 CARTON (83270-451-05) 20 capsule 2026-05-29 No No Current