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 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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N019557-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019557-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019557-001	AB	1	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019557-001	AB	1	`a50c72e98297…`

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
Ingredient	Strength
ETOPOSIDE	50 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2ab98334-79be-46be-f4f5-d4a6cc04219e	Product name	3	20180118
4896aaa2-df52-a28b-a484-cf928e9408ca	Product name	1	20140508
e9a73b62-e9c6-118b-a3be-022705d13855	Product name	1	20140508

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ETOPOSIDE	ETOPOSIDE	Onesource Specialty Pharma Limited	7bc994df-ee84-4ed7-80fa-737f70918953	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019557 application number: NDA019557 ndc (package): 83270-451-05 ndc (product): 83270-451 ndc11 (package): 83270045105
VePesid	ETOPOSIDE	Amneal Pharmaceuticals NY LLC	2a40f3ed-4a36-4616-af6c-b616140fd5ee	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019557 application number: NDA019557

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6PLQ3CP4P3	ETOPOSIDE	33419-42-0	ETOPOSIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197687	etoposide 50 MG Oral Capsule	PSN	7bc994df-ee84-4ed7-80fa-737f70918953	1
197687	etoposide 50 MG Oral Capsule	SCD	7bc994df-ee84-4ed7-80fa-737f70918953	1
197687	VP-16 50 MG Oral Capsule	SY	7bc994df-ee84-4ed7-80fa-737f70918953	1

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VePesid ® (Etoposide Capsules, USP) Rx only	Onesource Specialty Pharma Limited \| Onesource Specialty Pte. Limited \| Eirgen Pharma Ltd	2026-09-09	HUMAN PRESCRIPTION DRUG LABEL	3