VePesid

Product NDC
83270-451
Requested package NDC
83270-451-05
11-digit product format
832700451
Labeler code
83270
Product ID
83270-451_5b089f5a-a845-264e-e063-6294a90ae52a
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 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019557-001VEPESIDETOPOSIDE50MGCAPSULE / ORALABRLD1986-12-30
N019557-002VEPESIDETOPOSIDE100MGCAPSULE / ORALRLD1986-12-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N019557-001AB

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N019557-001VEPESID50MGCAPSULE / ORALABRLD1986-12-30c2088c7a36db…
2026-10-15 13:18:302026-09N019557-002VEPESID100MGCAPSULE / ORALRLD1986-12-30c2088c7a36db…
2026-09-14 22:38:342026-08N019557-001VEPESID50MGCAPSULE / ORALABRLD1986-12-3084e616aacf4f…
2026-09-14 22:38:342026-08N019557-002VEPESID100MGCAPSULE / ORALRLD1986-12-3084e616aacf4f…
2026-08-18 06:07:402026-07N019557-001VEPESID50MGCAPSULE / ORALABRLD1986-12-30caaa826d4ba7…
2026-08-18 06:07:402026-07N019557-002VEPESID100MGCAPSULE / ORALRLD1986-12-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019557-001VEPESID50MGCAPSULE / ORALABRLD1986-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019557-002VEPESID100MGCAPSULE / ORALRLD1986-12-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019557-001VEPESID50MGCAPSULE / ORALRLD1986-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019557-002VEPESID100MGCAPSULE / ORALRLD1986-12-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N019557-001VEPESID50MGCAPSULE / ORALRLD1986-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019557-002VEPESID100MGCAPSULE / ORALRLD1986-12-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019557-001VEPESID50MGCAPSULE / ORALRLD1986-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019557-002VEPESID100MGCAPSULE / ORALRLD1986-12-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019557-001VEPESID50MGCAPSULE / ORALRLD1986-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019557-002VEPESID100MGCAPSULE / ORALRLD1986-12-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019557-001VEPESID50MGCAPSULE / ORALRLD1986-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019557-002VEPESID100MGCAPSULE / ORALRLD1986-12-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019557-001VEPESID50MGCAPSULE / ORALRLD1986-12-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019557-002VEPESID100MGCAPSULE / ORALRLD1986-12-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019557-001VEPESID50MGCAPSULE / ORALRLD1986-12-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019557-002VEPESID100MGCAPSULE / ORALRLD1986-12-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019557-001VEPESID50MGCAPSULE / ORALRLD1986-12-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019557-002VEPESID100MGCAPSULE / ORALRLD1986-12-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019557-001VEPESID50MGCAPSULE / ORALRLD1986-12-30d06236e962d9…
2024-10-29 15:01 UTC2024-10N019557-002VEPESID100MGCAPSULE / ORALRLD1986-12-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019557-001VEPESID50MGCAPSULE / ORALRLD1986-12-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019557-002VEPESID100MGCAPSULE / ORALRLD1986-12-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019557-001VEPESID50MGCAPSULE / ORALRLD1986-12-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019557-002VEPESID100MGCAPSULE / ORALRLD1986-12-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019557-001VEPESID50MGCAPSULE / ORALRLD1986-12-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019557-002VEPESID100MGCAPSULE / ORALRLD1986-12-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019557-001VEPESID50MGCAPSULE / ORALRLD1986-12-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05N019557-002VEPESID100MGCAPSULE / ORALRLD1986-12-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019557-001VEPESID50MGCAPSULE / ORALRLD1986-12-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019557-002VEPESID100MGCAPSULE / ORALRLD1986-12-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019557-001VEPESID50MGCAPSULE / ORALRLD1986-12-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019557-002VEPESID100MGCAPSULE / ORALRLD1986-12-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019557-001VEPESID50MGCAPSULE / ORALRLD1986-12-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019557-002VEPESID100MGCAPSULE / ORALRLD1986-12-304b0b4de00fa7…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N019557-001AB1c2088c7a36db…
2026-09-14 22:38:342026-08N019557-001AB184e616aacf4f…
2026-08-18 06:07:402026-07N019557-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019557-001AB1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N019557-001AB1a50c72e98297…

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
VePesid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETOPOSIDE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6PLQ3CP4P3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
105592Internal RxNorm lookup
197687Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7bc994df-ee84-4ed7-80fa-737f70918953Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ab98334-79be-46be-f4f5-d4a6cc04219eProduct name320180118
4896aaa2-df52-a28b-a484-cf928e9408caProduct name120140508
e9a73b62-e9c6-118b-a3be-022705d13855Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83270-451-05ETOPOSIDE20 in 1 CARTONCAPSULE201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197687etoposide 50 MG Oral CapsulePSN7bc994df-ee84-4ed7-80fa-737f709189531
197687etoposide 50 MG Oral CapsuleSCD7bc994df-ee84-4ed7-80fa-737f709189531
197687VP-16 50 MG Oral CapsuleSY7bc994df-ee84-4ed7-80fa-737f709189531

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83270-451-058327004510520 CAPSULE in 1 CARTON (83270-451-05) 20 capsule2026-05-29NoNoCurrent