VePesid

Product NDC
69238-2811
11-digit product format
692382811
Labeler code
69238
Product ID
69238-2811_254bddbd-10bf-4415-a1a1-bae57127edc5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etoposide
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
NDA019557
Marketing category
NDA
Marketing start
2026-05-15
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 42.

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2019-12-13 00:20 UTC2019-12N019557-001VEPESID50MGCAPSULE / ORALRLD1986-12-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019557-002VEPESID100MGCAPSULE / ORALRLD1986-12-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019557-001VEPESID50MGCAPSULE / ORALRLD1986-12-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N019557-002VEPESID100MGCAPSULE / ORALRLD1986-12-30bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…

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
2a40f3ed-4a36-4616-af6c-b616140fd5eeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
2ab98334-79be-46be-f4f5-d4a6cc04219eProduct name320180118
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4896aaa2-df52-a28b-a484-cf928e9408caProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
e9a73b62-e9c6-118b-a3be-022705d13855Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-2811-2VePesid20 in 1 CARTONCAPSULE202

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ETOPOSIDEETOPOSIDEOnesource Specialty Pharma Limited7bc994df-ee84-4ed7-80fa-737f709189532026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 019557
application number: NDA019557
VePesidETOPOSIDEAmneal Pharmaceuticals NY LLC2a40f3ed-4a36-4616-af6c-b616140fd5ee2026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 019557
application number: NDA019557
ndc (product): 69238-2811

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197687etoposide 50 MG Oral CapsulePSN2a40f3ed-4a36-4616-af6c-b616140fd5ee2
105592VePesid 50 MG Oral CapsulePSN2a40f3ed-4a36-4616-af6c-b616140fd5ee2
105592etoposide 50 MG Oral Capsule [Vepesid]SBD2a40f3ed-4a36-4616-af6c-b616140fd5ee2
197687etoposide 50 MG Oral CapsuleSCD2a40f3ed-4a36-4616-af6c-b616140fd5ee2
105592Vepesid 50 MG Oral CapsuleSY2a40f3ed-4a36-4616-af6c-b616140fd5ee2
197687VP-16 50 MG Oral CapsuleSY2a40f3ed-4a36-4616-af6c-b616140fd5ee2
105592VP-16 50 MG Oral Capsule [Vepesid]SY2a40f3ed-4a36-4616-af6c-b616140fd5ee2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69238-2811-26923828110220 CAPSULE in 1 CARTON (69238-2811-2) 20 capsule2026-05-15NoNoCurrent